A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP SAFETY AND EFFICACY STUDY OF BI 10773 (10 MG AND 25 MG ADMINISTERED ORALLY ONCE DAILY) DURING 52 WEEKS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON MDI INSULIN REGIMEN ALONE OR WITH METFORMI

Not Applicable

• Registration Number: PER-041-11
• Lead Sponsor: Boehringer Ingelheim,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

1. DIAGNOSIS OF T2DM PRIOR TO INFORMED CONSENT.
2. MALE AND FEMALE PATIENTS ON DIET AND EXERCISE REGIMEN WHO ARE PRE-TREATED WITH MULTIPLE DAILY INJECTIONS (MDI) OF INSULIN ALONE OR IN COMBINATION WITH IMMEDIATE OR EXTENDED RELEASE METFORMIN. INSULIN THERAPY MUST INCLUDE BOTH BASAL AND PRANDIAL INSULIN. ANY TYPE OF BASAL AND ANY TYPE OF PRANDIAL INSULIN ARE ALLOWED. PRE-MIXED INSULIN PREPARATIONS ARE NOT ALLOWED.
3. TOTAL PRESCRIBED INSULIN DOSE MUST BE > 60 IU/DAY AT VISIT 1 (SCREENING) AND SHOULD NOT BE CHANGED WITHIN 12 WEEKS PRIOR RANDOMIZATION BY MORE THAN 10% FROM THE BASELINE VALUE AT RANDOMIZATION (VISIT 3).
4. STABLE METFORMIN THERAPY:
• DAILY DOSE ≥1500 MG/DAY OR MAXIMUM TOLERATED DOSE (MUST BE DOCUMENTED) OR MAXIMUM DOSE ACCORDING TO THE LOCAL LABEL.
• THE METFORMIN DOSE HAS TO BE UNCHANGED FOR 12 WEEKS BEFORE THE RANDOMIZATION (VISIT 3).
5. HbA1c ≥ 7.5% AND <10% AT VISIT 1 (SCREENING)
6. AGE ≥ 18 AND <80 YEARS AT VISIT 1 (SCREENING)
7. BODY MASS INDEX (BMI) ≥ 30 AND <45 KG/M² AT VISIT 1 (SCREENING)
8. SIGNED AND DATED WRITTEN INFORMED CONSENT BY DATE OF VISIT 1 IN ACCORDANCE WITH GCP AND LOCAL LEGISLATION.

Exclusion Criteria

1. UNCONTROLLED HYPERGLYCEMIA WITH A GLUCOSE LEVEL> 240 mg/dl (> 13.3 mmol/l) AFTER AN OVERNIGTH FAST DURING PLACEBO RUN-IN AND CONFIRMED BY SECOND MEASUREMENT (NOT ON THE SAME DAY).
2. ANY OTHER ANTIDIABETIC DRUG WITHIN 12 WEEKS PRIOR TO RANDOMIZATION EXCEPT THOSE MENTIONED IN INCLUSION CRITERION 2.
3. ACUTE CORONARY SYNDROME (NON-STEMI, STEMI AND UNSTABLE ANGINA PECTORIS) STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA) WITHIN 3 MONTHS PRIOR TO THE INFORMED CONSENT.
4. INDICATION OF LIVER DISEASE, DEFINED BY SERUM LEVELS OF EITHER ALANINE TRANSAMINASE (ALT, SGPT), ASPARTATE TRANSAMINASE (AST, SGOT) OR ALKALINE PHOSPHATASE ABOVE 3 TIMES UPPER LIMIT OF NORMAL (ULN) AS DETERMINED DURING SCREENING OR RUN-IN PERIOD.
5. IMPAIRED RENAL FUNCTION, DEFINED AS GFR <60 ml/min (MDRD FORMULA) AS DETERMINED DURING SCREENING AND/OR RUN-IN PERIOD.
6. BARIATRIC SURGERY WITHIN THE PAST TWO YEARS AND OTHER GASTROINTESTINAL SURGERIES THAT INDUCE CHRONIC MALABSORPTION.
7. MEDICAL HISTORY OF CANCER (EXCEPT FOR BASAL CELL CARCINOMA) OR TREATMENT FOR CANCER WITHIN THE LAST 5 YEARS. 

Study & Design

• Study Type: Interventional
• Study Design: Not specified