Health Condition 1: null- Type 2 Diabetes mellitus
Conditions
Interventions
Intervention1: IN-105: 4 Doses. Participation in the study was upto a maximum of 29 weeks
Control Intervention1: Placebo: 4 Doses. Participation in the study was upto a maximum of 29 weeks
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex with established diagnosis of type 2 diabetes mellitus as per revised WHO criteria for at least 24 weeks. Age - 30 to 65 years. Fasting Plasma C-peptide >0.6 ng/ml at screening. Body Mass Index (BMI) 18 to 29.9 kg/m2. Willingness to provide written informed consent to participate in the study. Glycosylated haemoglobin (HbA1c) concentrations of >7.5% and & Currently on stable dose of Metformin Extended-Release Tablets at doses ranging between 1 to 2 gm per day for at least 12 weeks prior to the screening visit. Willingness to fulfil the study requirements for the entire duration of the study.
Exclusion criteria
Exclusion criteria: History of hypersensitivity to the study drugs or to drugs with a similar chemical structure. History of severe or multiple allergies. Patients currently on other oral hypoglycemic agents other than extended release metformin or any alternative forms of medications known to affect the glycemic parameters. Type 1 diabetes mellitus. Fasting venous plasma glucose >200 mg/dl on two consecutive occasions at screening. Two or more severe hypoglycaemic episodes requiring hospitalization or intravenous glucose or treatment with glucagon in the past 6 months. Any hospitalization or emergency room visit due to poor diabetic control within the past 6 months. Complications of diabetes mellitus including a history or finding of moderate to severe Non Proliferative Diabetic Retinopathy or Proliferative Diabetic retinopathy of any severity, proteinuria >2+ by urine dipstick, serum creatinine of >1.8 mg/dl for males or >1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease which has resulted in amputation, chronic foot ulcer, claudication or absent pulses, history of autonomic neuropathy. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator except patients diagnosed with essential hypertension and/or hyperlipidemia if well controlled on stable doses of antihypertensive and/or hypolipidemic drugs for at least 3 months prior to the screening visit. Impaired hepatic function as shown by an increased Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range and/or Bilirubin greater than 1.5 times the upper limit of normal range at study entry. History of cancer in the last 5 years. Any condition which requires administration of systemic corticosteroid in the last 2 weeks prior to screening or any condition which requires chronic treatment with systemic corticosteroids. Pregnancy, lactation, or planned pregnancy during the study duration. Women of childbearing potential (any women who is not surgically sterile or > 2 years post menopause) must give consent for using a reliable method of contraception (e.g. double-barrier, tubal ligation or stable hormonal contraception) throughout the study period. Women who become pregnant during the study must be discontinued from the study, but followed for pregnancy outcome. Blood donation within the last 30 days. Treatment by another investigational agent during the 3 months prior to inclusion in the trial. Current or past treatment with insulin or insulin analogues to control diabetes. Hepatitis B, hepatitis C and/or HIV positive patients. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair patient safety or protocol compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to week 24.Timepoint: from randomization (V3) to week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in HbAIC from baseline to week 14Timepoint: See under Outcome;10.Investigators Global assessment of tolerabilityTimepoint: NA;4. Change in serum lipids,Body weight, BMI and waist circumference from baselineto weeks 14 and week 24.Timepoint: week 14 and week 24;5. Change in homeostasis model assessment beta cell (Homa-B) and Insulin resistance (HOMA IR) from baseline to weeks 14 and week 24Timepoint: Week 14 and week 24;6. Change in C -peptide from baseline to weeks 14 and week 24.Timepoint: Week 14 and Week 24;7. Adverse events (including clinically significant laboratory abnormalities)Timepoint: NA;8. Immunogenecity by anti-insulin antibody titre at week 8 14 and week 24.Timepoint: Week 8, 14 and 24;Change in average SMBG,FPG and 1- and 2-hour standardized test meal PPG valuefrom baseline to weeks 14 and weeks 24Timepoint: week 14 and week 24;Fundoscopic changesTimepoint: NA;Proprotion of patients achievingHbAIC lesser than or equalto 7% and lesser than or equal to 6.5% at the end of week 14 and 24.Timepoint: week14 and week 24 | — |
Countries
India
Contacts
Public ContactDr Sarika S Deodhar
Outcome results
None listed