Diabetese- One reason not to Worry ! A new Clinically researched NATURAL PRODUCT is here: DBC-24

Clinically Approved & Safe Anti-Diabetic product Introducing

Years of Scientific ResearchMonths of Pre-clinical StudiesMonths of Clinical StudiesApproval of Clinical Data & Recognition by

various MOH’s

Devoid of Chemicals but full with

‘Natural Synergy’

Highlights:• Enhances islet cells regeneration activity• Reduction of Blood sugar level• Reducing Insulin resistance.• Perfect adjuvant with OHA’s

DBC-24 is ‘Natural’ & ‘non synthetic’ answer on: HOW to effectively manage blood glucose level ?

DBC-24’s patented combination of herbs is proven to be very effective for diabetic patients.

Benefits : Comparable to Chemical based Drugs

Helps control, monitor & normalize blood sugar level

Helps Manage TYPE II DiabetesHelps manage

Polycystic Ovarian Syndrome (PCOS)

Increase Glucose Utilization& inhibits glucose absorption

Effectively controls Insulin Resistance

Result of Synergy(Within 90 days):

13.3% reduction in mean fasting blood sugar level .

Mean postprandial blood sugar level reduced from baseline value to 12.87%.

Mean serum insulin level reduced from baseline value to 10.2%.

Gymnema sylvestre

Regulates the blood sugar level of the body and increases the secretion of insulin. This herb possesses anti-diabetic property. Gymnema sylvestre also promotes the regeneration of islet cells.

Enicostemma littorale

Possesses antioxidant property and enhances glucose induced insulin release. This herb also maintains the blood glucose levels.

Pterocarpus marcupium

Possesses hypoglycaemic property. It helps in the production of more insulin and conversion of pro insulin to insulin.

DBC 24: Mechanism Of Action

Syzygium cumminii

Helps in the regeneration of pancreatic Beta (β)cells

Significantly decreases the blood glucose as well as triglyceridemic levels

Emblica officinalis

Restore the body's ability to control blood sugar levels by boosting the effectiveness of the body's own insulin.

Improvement in glucose tolerance and diminished insulin requirements.

Enhances islet cells regeneration activity.

Checks glucose absorption from intestine and inhibits alpha-glycosidase.

Increases utilization of glucose by increasing the activities of enzymes responsible for utilization of glucose by insulin-dependant pathways

Natures Energy works in Synergy

DBC 24 :Improves response to conventional Oral Hypoglycemic Agents (OHAs) and eventually helps reduce intake of OHA's.

Scientific Evidence : Human Clinical trial

Inclusion criteria: 1. Subjects suffering from type 2 diabetes mellitus for more than one year, and stabilized on mono / poly-drug oral anti-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea and Biguanids) for at least last 3 months.

2. Subjects having HbA1C value between 7-10% (both inclusive) at screening.

3. Subjects having Fasting Plasma Glucose 126-252 mg/dl (both inclusive) at screening.

4. Subjects of male gender or a non pregnant, non lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.

5. Subjects having a body mass index (BMI) of 20 ? 35 kg/m2.

6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Randomized, Double blind, Placebo controlled, Phase 2 Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an Add-on therapy with Oral Hypoglycemic agents (OHA) in Type 2 Diabetic Patients.

109 patients suffering from type II diabetes mellitus

1. Subjects on insulin therapy or on oral hypoglycemic agents other than Sulfonylurea and Biaguanides.

2. Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2.

3. Subjects having known hepatic or renal disease.

4. Subjects having an active malignancy.

5. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.

6. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.

7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.

9. Use of any other investigational drug within 1 month prior to randomization

10. Known hypersensitivity to ingredients used in study drug

11. Pregnant and Lactating females.

Exclusion criteria:

Dosage and Duration of Treatment: Two tablets twice daily orally before meals as an add on therapy to oral hypoglycaemic agent(s) for three months(90 Days)

Primary Outcome(s)1) Changes in Fasting and Postprandial Plasma Glucose levels .

2) Changes in HbA1C% Value

Secondary Outcome(s)1) Changes in fasting Serum insulin level

2) Reduction in dose of OHAs

3) Improvement in clinical symptoms of Type 2 DM

4) Global assessment for overall improvement by the subject

5) Global assessment for overall improvement by the investigator

6.) Tolerability of study drugs assessment by study subject and investigator

7) Laboratory parameters like Liver function tests (LFT), renal function tests (RFT), Lipid Profile, C complete blood count (CBC), ESR, Hb% and Urine Examination

Time point: Day 0, Day 30, Day 60 and Day 90

In all recruited subjects• 62 subjects completed the study (33 subjects were in Group A and 29

subjects were in group B).• 23 subjects dropped out prematurely (10 in group A and 13 in group B)

Details of Clinical Trial

PATIENTS WERE RANDOMISED & DIVIDED IN 2 GROUPS

GROUP A : METFORMIN + DBC

GROUP B : METFORMIN + PLACEBO

Effect of Trial Drugs on Mean Fasting Blood Sugar Level

149.82 147.56

158.83

135.14

164.52

142.64

159.98144.79

0

20

40

60

80

100

120

140

160

180

Day 0 Day 30 Day 60 Day 90Treatment Duration in Days

Me

an

Fa

sti

ng

Blo

od

Su

ga

r V

alu

e (

mg

/dl)

Group AGroup B

Graph 1: Effect of trial drugs on Fasting Blood Sugar Level:

At the end of treatment, there was 13.3% reduction in mean fasting blood sugar level among Group A that was statistically significant.

Among Group B, there was 9.5% fall in mean fasting blood sugar level that was statistically insignificant.

Group A: Metformin+ DBCGroup B : Metformin + Placebo

Effect of trial drugs on mean glycosylated hemoglobin (HbA1c %)

Effect of Trial Drugs on Mean Glycosylated Hemoglobin %

8.94

8.16

8.49

7.98

7.4

7.6

7.8

8

8.2

8.4

8.6

8.8

9

9.2

Day 0 Day 90Treatment Duration in Days

Mean

Gly

co

syla

ted

Hem

og

lob

in %

Group A

Group B

At the end of treatment, 8.7% reduction from baseline value in mean Glycosylated Hemoglobin was observed in subjects of Group A,

6.0% reduction from baseline in mean glycosylated hemoglobin was observed in subjects of group B.

On evaluation fall in mean glycosylated hemoglobin was more in group A than group B.

Group A: Metformin+ DBCGroup B : Metformin + Placebo

Effect of trial drugs on mean serum insulin level:

Effect of Trial Drugs on Mean Serum Insulin Level

7.72

10.248.6

8.18

0

2

4

6

8

10

12

Day 0 Day 90Treatment Duration in Days

Me

an

Se

rum

In

su

lin

Le

ve

l Group A

Group B

At the end of treatment, there was 10.2% reduction in mean serum insulin among subjects of Group A, which was statistically insignificant.

There was 25.2% increase in mean serum insulin level from baseline value to the end of study value among subjects of group B, which was statistically significant.

Group A: Metformin+ DBCGroup B : Metformin + Placebo

At the end of the study, there was 13.3% reduction (statistically significant) in the mean fasting blood sugar level among subjects of group A (DBC GROUP) , where as 9.5% reduction (statistically insignificant) in the mean fasting blood sugar was observed among subjects of group B(NON DBC).

DBC scored over placebo as an adjuvant to OHAs in the management of fasting blood sugar in type II diabetic subjects. At the end of the treatment, 12.87% (statistically significant) fall was observed in mean postprandial blood sugar level among the subjects of Group A (DBC), where as 0.59% rise was observed in mean postprandial blood sugar level among subjects of group (NON DBC) .

This indicates that OHAs along with placebo failed to control postprandial blood sugar levels in type II diabetic subjects, where as drug DBC proved to be effective as an adjuvant to OHAs in the management of postprandial blood sugar levels in type II diabetic population.

Approximately 50 other Laboratory & Clinical parameters were evaluated…

What is important………. ??

Important Fact…cannot be ignored

In both the groups, no change in dosages of background OHAs was made during the entire study period by the investigator

At the end of the trial, 8.7% reduction was observed in the mean glycosylated hemoglobin percentage among subjects of group A, whereas 6% reduction in the mean glycosylated hemoglobin was observed among subjects of group B.

We all agree : Glaciated hemoglobin (HbA1c) concentration is an indicator of average blood glucose concentration over three months and has been suggested as a tool in screening of diabetes as well as monitoring control of blood sugar levels in the management of diabetes.

DBC 24 proved to be superior over placebo as an adjuvant to OHAs for better control over glaciated hemoglobin%.

Did you pay attention ?

In the present study, 10.2% reduction in the mean serum insulin level was observed among subjects of Group A (DBC Group) as compared to 25.2% increase in the mean serum insulin level among subjects of group B (NON DBC GROUP).

This indicates that DBC 24 as an adjuvant to OHAs was probably able decrease insulin resistance / sensitize insulin receptors to utilize insulin available in the body to control blood sugar levels, where as placebo failed to decrease insulin resistance.

Both the groups were effectively able to reduce symptoms of diabetes such polyurea, polyphasia, polydypsia and fatigue.

At the end of the study, according to physician’s and patient’s assessment for overall efficacy, good to excellent overall efficacy was observed in 72.7% subjects of group A(DBC+ Metformin), whereas good to excellent overall efficacy was observed in 55.2% subjects of group B(Only Metformin).

DBC-24 was able to sensitize insulin receptors.

Natural synergy makes DBC Different

It has been observed that defective insulin secretion and insulin resistance are the two main factors causing the development and progression of type 2 diabetes.

• After an initial improvement, glycemic control continues to deterio rate

despite the use of oral hypoglycemic agents aimed to enhance insulin se cretion and to reduce insulin resistance.

• This deterioration can be attributed to the progressive decline of β-cell function, and insulin treatment is usually required in type 2 diabetic pa tients who are not able to obtain good glycemic control with oral hypoglycemic agents.

“Although new treatment options for type 2 diabetic patients are increasingly available, agreement on the most effective treatment approach for individual patients has not been achieved”.

In the UK Prospective Diabetes Study*:

The present study provides the evidence in support of the potential efficacy and safety of the herbal formulation ‘DBC 24’ as an adjuvant to OHAs in the management of type II diabetes mellitus.

DBC 24 as add on therapy helps to reduce insulin resistance/sensitize insulin receptors in subjects having poor response to OHAs.

Hence it can be concluded that DBC 24 can be used as add on therapy to OHAs to avoid insulin resistance/ failure of glycemic control, which usually happens after prolong use of OHAs.

Natural synergy makes DBC Different

PCOS occurs in 5% to 10% of women and is the most common cause of infertility in women.

Irregular menstrual Cycle

Weight Gain

Acne & growth of facial hair

multiple, small cysts in the ovaries.

Elevated insulin levels and insulin resistance.

skin discolorations.

Dandruff.

high cholesterol levels.

elevated blood pressure.

Any of the above symptoms and signs may be absent in PCOS, with the exception of irregular or no menstrual periods. All women with PCOS will have irregular or no menstrual periods .

Malfunction of the body's blood sugar control system (insulin system) is frequent in women with PCOS, who often have insulin resistance and elevated blood insulin levels, and researchers believe that these abnormalities may be related to the development of PCOS.

It is also known that the ovaries of women with PCOS produce excess amounts of male hormones known as androgens. This excessive production of male hormones may be a result of or related to the abnormalities in insulin production.

Evidence Based Science:

Hyperandrogenic anovulation (PCOS): A unique disorder of insulin action associated with an increased risk of non-insulin-dependent diabetes mellitus

American Journal of Medicine, Volume 98, Issue 1, Supplement 1, Pages S33–S39, January 16, 1995

“Evidence suggests that women with polycystic ovary syndrome have a unique disorder of insulin action and are at increased risk to develop non-insulin-dependent diabetes mellitus. Further, non-insulin-dependent diabetes mellitus in women with polycystic ovary syndrome has a substantially earlier age of onset (third to fourth decades) than it does in the general population (sixth to seventh decades)”.

“Women with PCOS have profound peripheral insulin resistance, independent of obesity, due to a post-binding defect in insulin signalling ”.

The evidence is growing :

Therapeutic rationale (For PCOS): Polycystic Ovarian Syndrome (PCOS) affects 6-10 % of women population and it is very often associated with insulin resistance. PCOS leads to amneorrhoea, anovulation, oligomenorrhoea, hirsutism etc.

DBC-24 is a researched HERBAL formulation marketed by TULIP LAB. It is indicated in PCOS for improving insulin sensitivity, thereby promoting ovulation and reduced levels of testosterone. DBC helps in controlling hirsutism, acne, alopecia and obesity.

Treatment Protocol DBC-24 works very well for women with insulin-resistance. 1-2 tablets twice a day, half an hour before meals decreases gastrointestinal absorption of glucose from the meals, regulates the insulin response of the pancreas and increases peripheral utilization of glucose. A treatment protocol with DBC-24 lasting for 3-4 months restores normal ovulation in a large percentage of women.

With DBC-24: Get the ‘NATURAL SYNERGY’ for effective management & Treatment of PCOS:

Advantages of taking DBC-24 over Metformin: DBC-24 has no side effects where as patients

taking metformin have complaints of side effects like gastrointestinal problems namely nausea, vomiting, abdominal pain, loss of appetite and diarrhoea.

DBC-24 helps in weight loss and helps the patients suffering from obesity but metformin does not help curing obesity in any way.

Metformin is expensive than most of the sulfonylurea’s available where as DBC-24 is cost effective and is not expensive.

Long-term use of metformin has been associated with increased homocysteine levels and malabsorption of vitamin B12. Higher doses and prolonged use are associated with increased incidence of B12 deficiency.

DBC-24 in PCOS improves ovulatory function and several metabolic derangements associated with insulin resistance. DBC-24 decreases the insulin resistance and thereby corrects the three axes namely metabolic, reproductive and steroidogenic.

DBC-24 provides a sense of well-being and feeling of less tired and less fatigue where as patients taking metformin takes some time adjusting to the medicine.

DBC-24 being the herbal medicine helps the patient in curing diabetes and PCOS in a longer run without any side effects.DBC-24 does not show any signs of clinical hypoglycemia unlike sulfonylureas.

DBC-24 is safe and effective insulin sensitizer for the treatment of PCOS.

Lowers the lipid levels & protects against cardiovascular diseases.

Cost effective for long-term use.

Improves quality of life and restores libido.

DBC 24 : A Better Choice

INDICATIONS: As an add-on therapy in the management of Type 2 Diabetes mellitus, poorly

responding to OHAs,

Newly diagnosed mild to moderate Type 2 Diabetes mellitus, Impaired Glucose Tolerance (IGT).

As a preventive medicine against the complications of Diabetes mellitus.

For management of Polycystic Ovarian syndrome(PCOS)

Dosage: 2 Tablets to be taken Twice a day just before taking meals.

Long term dosage has been found safe with good tolerance.

Cost effective & Devoid of side effects of CHEMICAL based medicines.

60 Tablets in a Bottle: 15 days course in 1 bottle

Why 24 ???

DBC provides round the clock ( 24 Hrs. ) protection against diabetes & controls Insulin Resistance

For Out Licensing/Contract manufacturing Queries connect with-Mr. Vishal Chandra, General Manager International Business. E-mail: [email protected], [email protected]: vishalukraine

Tulip Lab Private Ltd.