Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Linagliptin; Metformin

Criteria

Inclusion criteria:

1. Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent

2. Male and female patients on diet and exercise regimen who are drug-naïve

3. Glycosylated haemoglobin A1c (HbA1c) at V1a >/=7.5 %<11% for main group and HbA1c >/= 11.0 % for the additional parallel group

4. Age >/= 18 and

5. Body Mass Index(BMI)

6. Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation

Exclusion criteria:

1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase

2. In main group, the patients with investigational medicinal product(IMP) compliance < 80 % or >120 % during 2 weeks placebo run in period

3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation

4. Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a

5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo

6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening

7. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.

8. Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.

9. Pre-menopausal women (last menstruationnursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study

10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.

11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) < 60 ml/min

12. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption

13. Dehydration by clinical judgement of the investigator

14. Clinical detected unstable or acute congestive heart failure

15. Acute or chronic metabolic acidosis (present in patient history)

16. Hereditary galactose intolerance

17. Known history of pancreatitis and chronic pancreatitis

18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.

19. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator