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Clinical Trials/CTRI/2009/091/000605
CTRI/2009/091/000605
Completed
Phase 2

A 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.

Tulip Lab Pvt Ltd0 sites80 target enrollmentTBD
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ConditionsHealth Condition 1: null- Type II Diabetes mellitus

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: null- Type II Diabetes mellitus
Sponsor
Tulip Lab Pvt Ltd
Enrollment
80
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Tulip Lab Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\. Subjects suffering from type 2 diabetes mellitus for more than one year, and stabilized on mono / polydrug oral anti\-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea and Biaguanides) 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 nonpregnant, nonlactating 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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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