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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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