This study is done to assess Effectiveness and Safety study of a three drug combination with a two drug combination for the treatment of type 2 diabetes mellitus in patients who have never received insulin.

Suspended

• Conditions: Treatment in insulin-naïve patients with type 2 diabetes

• Registration Number: CTRI/2011/06/001841
• Lead Sponsor: Abbott India Limited

Brief Summary

- Protocol Title: This is a randomized, single centre, open lable study to assess the effectiveness and safety of FDC glimepiride 2mg+metformin500 mg+pioglitazone 15 mg VS Insulin 70/30 + Metformin 500 mg.

- This is IIS ( Investigator initiated study).

- Methodology:

- Screening: Patients would be evaluated for eligibility and baseline laboratory investigations shall be performed Randomization: The eligible patients shall be randomized into 2 arms (Arm A & B) Arm A: Patients shall receive FDC of either: 1> Glimipiride 1 mg + Metformin 500 SR + Pioglitazone 15 mg OD (Triobimet 1)OR 2> Glimipiride 2 mg + Metformin 500 SR + Pioglitazone 15 mg OD (Triobimet 2) (As per investigators decision)

- Arm B: Patients shall receive Insulin 70/30 + Metformin SR Therapy to be initiated with insulin 70/30 mix b.i.d. (starting dose, 0.75 units/kg). Two-thirds of the dose to be given before breakfast and the remainder before dinner. Dose adjustments of 10% of the current dose can be done at discretion of investigator, until the glycemic (FPG and postprandial glucose) targets are achieved. The patient shall continue to receive Metformin SR once a day in morning in addition to Insulin 70/30 mix In both the arms the dose of oral anti-diabetic agents shall be titrated as per the target HbA1c

- Duration of Treatment: The treatment period will be of 12 wks. The study period will be approximately 90 days (Screening 7 days + Treatment period 12 weeks)

- Duration of follow-up: Each patient shall be followed up for 3 months

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-20
• Last Update Posted: 2011-10-17

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Subjects meeting all of the following criteria will be considered for enrollment into the study -Subjects or their legally-acceptable representatives (LARs) must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• 18 years of age, upper limit at the discretion of Investigator.
• Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix A) at least 6months prior to screening.
• HbA1C greater than 8% -Insulin naive -Patients who are either not receiving or are on a constant dose of lipid lowering agent/s since last three months.
• Patients with stable dietary and exercise pattern since three months and willing to follow the same for the entire trial duration.
• (There is no upper limit to age).

Exclusion Criteria

• Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months Cardiac status New York Heart Association (NYHA) III-IV Impaired renal function as shown by, but not limited to, serum creatinine more than or equal to 1.5 mg/dL for males, more than or equal to 1.4 mg/dL for females Use of Oral hypoglycemic agent in the past 3 months Acute infection Clinically significant peripheral edema Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range History of hypoglycemia unawareness Pregnancy or lactation Known hypersensitivity to any Oral hypoglycemic agent.
• Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years Diagnosis of dementia Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study Indications of Insulin in Type 2 Diabetes At onset, if FBG is 250 mg/dl and/or ketonuria.
• In stressful situations (acute myocardial infarction, stroke, fulminant infections, trauma).
• During pregnancy.
• Perioperative state.
• Hepatic and renal decompensation.
• Diabetic coma Idiosyncrasies to oral anti-diabetic agents.
• Secondary failure to OHA.
• Diabetics on steroids Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in HbA1c from baseline to Week 12	week 12

Secondary Outcome Measures

Name	Time	Method
-Percentage of subjects achieving an HbA1C decrease by 1%	-Change from baseline to week 12 of FPG and PPG

Trial Locations

Locations (1)

Shivam clinic and Research centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Shivam clinic and Research centre

🇮🇳Mumbai, MAHARASHTRA, India

DrMahesh Padsalge

Principal investigator

022-27719497

drmaheshpadsalge@gmail.com