CTRI/2023/03/050804
Not yet recruiting
Phase 3
A Randomized, Assessor Blind, Active-Controlled, Multicenter, Parallel Group, Non-Inferiority Study to compare the Efficacy and Safety of GEN1501 (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) of GeneSys Biologics Pvt. Ltd., India with LANTUS® (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) in patients with Type 2 Diabetes Mellitus on Uncontrolled Oral Antidiabetic therapy (OAD)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GeneSys Biologics Pvt. Ltd.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Willing to give informed consent.
- •2\. Age: between 18\-65 years, both inclusive.
- •3\. Insulin\- naïve male or female subjects with type 2 diabetes mellitus, as per WHO Criteria 2006 \[fasting plasma glucose \= 7\.0mmol/l (126mg/dl) or 2–h plasma glucose \= 11\.1mmol/l (200mg/dl)].
- •4\. Established diagnosis of type 2 diabetes for more than one year.
- •5\. On oral antidiabetic therapy \[\= two drugs\- AGI (a\-Glucosidase inhibitors), DPP\-4 (Dipeptidyl peptidase\-4\) inhibitors, MEG (Meglitinides), MET (metformin), SU (Sulfonylureas), GLP1\-RA (Glucagon\-like peptide\-1 receptor agonists)] stable doses, for at least 12 weeks prior to study entry.
- •6\. Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening.
- •7\. Body Mass Index 18 to 35 Kg/m2\.
- •8\. Glycosylated hemoglobin \- HbA1C \= 7\.0 and \= 10\.0% and stratification criteria \= 8\.5% and \> 8\.5%.
- •9\. Women of child\-bearing potential willing to use an effective method of contraception.
- •10\. Ability and willingness to perform self\-monitored blood glucose (SMBG).
Exclusion Criteria
- •1\. Type 1 diabetes mellitus
- •2\. Type 2 diabetic subjects on Thiazolidinedione (TZD) therapy
- •3\. Used glucagon\-like peptide 1 (GLP\-1\) agonist, thiazolidinediones (TZDs) within the previous 90 days.
- •4\. More than one episode of severe hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, within 6 months prior to study entry
- •5\. An episode of moderate to severe Diabetic ketoacidosis in the last three months prior to screening needing inpatient or outpatient care.
- •6\. Clinically significant abnormal hepatic (e.g., AST or ALT greater than 2\.5x ULN, or total bilirubin greater than 1\.5x ULN) or renal function lab tests (e.g., creatinine greater than 1\.25x ULN) suggestive of hepatic or renal impairment.
- •7\. History of renal transplant.
- •8\. Severe peripheral vascular disease which has resulted in amputation, chronic foot ulcer, claudication or absent pulses.
- •9\. Known history of autonomic neuropathy. Pregnancy or women intending to become pregnant during the trial period and Breast feeding.
- •10\. Blood donation within the last 30 days.
Outcomes
Primary Outcomes
Not specified
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