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

A prospective, multicentre, comparative, open label, randomised parallel phase III study to assess efficacy and safety of recombinant insulin glargine compared with LantusÂ® in patients with Type II Diabetes Mellitus uncontrolled on OAD therapy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000012

Enrollment

278

Registered

2010-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type II Diabetes Mellitus uncontrolled on Oral Anti Diabetic Therapy

Interventions

Intervention1: Recombinant Insulin Glargine: Starting Dose is 10 IU once daily subcutaneously before sleep along with oral antidiabetic. The dose of recombinant insulin glargine needs to be adjusted

Eligibility

Inclusion criteria

Inclusion criteria: Patients are eligible for participation into the study if all of the following criteria are met: Â· Insulin naÃ¯ve male or female type II diabetes mellitus patient Â· Age between 18 and 75 years. Â· At least 12 months history of Type II Diabetes Â· Inadequate glycemic control on stable doses of one or more oral antidiabetics for more tah or equal to 3 months Â· HbA1c between 7.5 to 10 %. Â· FBG more than or equal to 126 mg/dl, and less than 234 mg/dl. Â· Body Mass Index less than or equal to 40 kg/m2 Â· 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. Â· Willing and able to give informed consent and comply with study procedures.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Efficacy: Change in HbA1c from baseline to treatment period.Timepoint: Efficacy: 24 Weeks;Efficacy: Change in HbA1c from baseline to treatment period.Timepoint: Efficacy: 24 Weeks	—

Secondary

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

Countries

India

Contacts

Public ContactDr Deepali Mittal

Project Physician

mita.nandy@lglsi.com0124-4830000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026