A clinical Trial to compare the effects and safety of different combinations of the trial drug and metformin over 24 weeks in drug naïve or previously treated (after with holding the treatment for 4 weeks) type 2 diabetic patients with poor control of blood sugar levels.

Phase 3

Completed

• Conditions: Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2009/091/000125
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH Co

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: 792

Inclusion Criteria

1.Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment drug naïve patients or previously treated patients with not more than one oral antidiabetic drug. Antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent

2. Diagnosis of type 2 diabetes prior to informed consent

3. Glycosylated haemoglobin A1c (HbA1c) at Visit 1a (Screening): For patients undergoing wash-out (pre-treated patients): HbA1c ≥ 7.0 to ≤ 10.5 %

For naïve patients not undergoing wash-out: HbA1c ≥ 7.5 to < 11.0%

4. Glycosylated haemoglobin A1c (HbA1c) ≥ 7.5 to < 11.0% at Visit 2

(Start of Run-in)

5.Patients with very poor glycaemic control [HbA1c ≥ 11 %, determined by examination at Visit 1a (naïve patients) or at Visit 2 (naïve and pre-treated patients)] will be eligible to participate in an additional open-label study arm

6. Age ≥ 18 and ≤ 80 years at Visit 1a (Screening)

7. BMI (Body Mass Index) ≤ 40 kg/m2 at Visit 1a (Screening)

8. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion Criteria

A history of coronary heart disease or stroke, serum creatinine >1.5 mg/dl, albuminuria >40 μg/min, and use of lipid-lowering drugs, aspirin, or other antihypertensive agents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified