A clinical trial to assess the efficacy and safety of recombinant insulin glargine compared with Lantus® in patients with Type II Diabetes Mellitus uncontrolled on OAD Therapy.

Phase 3

Completed

• Conditions: Type II Diabetes Mellitus uncontrolled on Oral Anti Diabetic Therapy

• Registration Number: CTRI/2010/091/000012
• Lead Sponsor: LG Life Sciences India Pvt Ltd

Brief Summary

This is a prospective, multicentre, comparative, open label, randomised parallel phase III clinical study with primary objective to assess efficacy and safety of recombinant insulin glargine compared with Lantus® in patients with Type II Diabetes Mellitus uncontrolled on Oral Anti-Diabetic therapy, that will be conducted in nine investigator sites in India.The secondary outcome will be To compare test drug and Lantus® with respect to the (a) Glycemic control as determined by self monitored blood glucose concentrations (b) Change from baseline to endpoint in fasting blood glucose; and (c) Incidence of Hypoglycemia

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-03
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• Patients are eligible for participation into the study if all of the following criteria are met: · Insulin naïve male or female type II diabetes mellitus patient · Age between 18 and 75 years.
• · At least 12 months history of Type II Diabetes · Inadequate glycemic control on stable doses of one or more oral antidiabetics for more tah or equal to 3 months · HbA1c between 7.5 to 10 %.
• · FBG more than or equal to 126 mg/dl, and less than 234 mg/dl.
• · Body Mass Index less than or equal to 40 kg/m2 · Willing and able to measure Fasting Blood Glucose by blood glucose meter and 8-time point blood glucose within 24 hours, once before every visit.
• · Willing and able to give informed consent and comply with study procedures.

Exclusion Criteria

• Type I Diabetes Mellitus· Prior use of insulin except for gestational diabetes or for less than or equal to 1 week· Pancreatitis or Pancreatectomy· History of ketoacidosis· Clinically relevant cardiovascular, hepatic, neurological, endocrine, gastrointestinal, urinary,reproductive or other major systemic diseases· Impaired renal function with serum creatinine greater than or equal to 1.5 mg/dl· Impaired hepatic function as shown by ALT or AST greater than twice the upper limit of normal· Proliferative diabetic retinopathy.· Use of other agents affecting glycemic control (non-selective beta- blockers, weight loss agents.)· History of myocardial infarction· Female patient who is pregnant, wishes to become pregnant during study period, or is breastfeeding..
• Recent history (within 60 days) or likely future use of systemic glucocorticosteroids or other immunosuppressant or cytotoxic therapy.· Self reported inability to recognize hypoglycemia· Being a night shift worker· Participation/Treatment with any investigational drug or biologic in a clinical study within the past 30 days.· History of drug or alcohol abuse.· Any other condition which, in the judgment of the investigator, makes the patient unsuitable to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
baseline to treatment period.	Efficacy: 24 Weeks
Efficacy: Change in HbA1c from	Efficacy: 24 Weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy:Mean blood glucose in two treatment groups (8 time-point BG value per 24 hrs)	24 Weeks treatment period
Change in FBG from baseline to endpoint in the two treatment groups.	24 weeks treatment period
Hypoglycemic incidence rate in the two treatment groups	24 weeks treatment period

Trial Locations

Locations (10)

CHL - Apollo Hospitals, Indore; 🇮🇳 Indore, MADHYA PRADESH, India

Christian Medical College, Ludhiana; 🇮🇳 Ludhiana, PUNJAB, India

Department of Endocrinology, Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Diabetes Clinic & Research Centre,Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Diabetes, Thyroid and Endocrine Centre, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Hormone Care & Research Centre, Ghaziabad; 🇮🇳 Ghaziabad, UTTAR PRADESH, India

Mahatma Gandhi Medical College & Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

MV Hospital & Research Centre,Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

North Delhi Diabetes Centre, Delhi; 🇮🇳 Delhi, DELHI, India

SR Kalla Memorial Gastro & General Hospital, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

CHL - Apollo Hospitals, Indore

🇮🇳Indore, MADHYA PRADESH, India

Dr. Sandeep Julka

Principal investigator

sandeep_julka@yahoo.com