Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

NCT ID: NCT01215097

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-04-30

Brief Summary

In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Linagliptin

once a day

Group Type: EXPERIMENTAL

Linagliptin

Intervention Type: DRUG

once a day

placebo

once a day

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

once a day

Interventions

Linagliptin

once a day

Intervention Type: DRUG

placebo

once a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug (antidiabetic therapy has to be unchanged for 6 weeks prior to informed consent and patients should receive standard diet and exercise counseling) A dose of >/=1500 mg/day metformin is required for inclusion into the trial. The dosage needs to be stable for at least 8 weeks before randomisation. Patients with a total daily dose of less than 1500 mg metformin will only be included; if the investigator has documented them to be on their maximum tolerated dose (also in this case the 8 week time interval will apply for a stable dose).

2. Diagnosis of type 2 diabetes prior to informed consent

3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):

For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%

4. Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)

5. Age = 18 and < 80 years at Visit 1a (Screening)

6. BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)

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

Exclusion Criteria

1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent

2. Impaired hepatic function, defined by serum levels of either Alanine transaminase,Aspartate transaminase, or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a

3. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day).

4. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo

5. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent

6. Treatment with an injectable Glucagon-like peptide- 1 (GLP-1) analogue (e.g. exenatide) , Dipeptidyl-Peptidase 4 (DPP-IV) inhibitor within 3 months prior to informed consent

7. Treatment with insulin within 3 months prior to informed consent

8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent.

9. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse

10. Participation in another trial with an investigational drug within 2 months prior to informed consent

11. Pre-menopausal women (last menstruation =1 year prior to informed consent) who:

• are nursing 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 and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.

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

13. Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)

14. Dehydration by clinical judgement of the investigator

15. Unstable or acute congestive heart failure

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

17. Hereditary galactose intolerance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1218.65.86007 Boehringer Ingelheim Investigational Site

Beijing, , China

1218.65.86011 Boehringer Ingelheim Investigational Site

Chongqing, , China

1218.65.86008 Boehringer Ingelheim Investigational Site

Dalian, , China

1218.65.86010 Boehringer Ingelheim Investigational Site

Fuzhou, , China

1218.65.86014 Boehringer Ingelheim Investigational Site

Hangzhou, , China

1218.65.86005 Boehringer Ingelheim Investigational Site

Hefei, , China

1218.65.86006 Boehringer Ingelheim Investigational Site

Hefei, , China

1218.65.86012 Boehringer Ingelheim Investigational Site

Nanjing, , China

1218.65.86001 Boehringer Ingelheim Investigational Site

Shanghai, , China

1218.65.86002 Boehringer Ingelheim Investigational Site

Shanghai, , China

1218.65.86003 Boehringer Ingelheim Investigational Site

Shanghai, , China

1218.65.86004 Boehringer Ingelheim Investigational Site

Suzhou, , China

1218.65.86015 Boehringer Ingelheim Investigational Site

Wenzhou, , China

1218.65.86009 Boehringer Ingelheim Investigational Site

Wuhan, , China

1218.65.86013 Boehringer Ingelheim Investigational Site

Yangzhou, , China

1218.65.60002 Boehringer Ingelheim Investigational Site

Johor Bahru, , Malaysia

1218.65.60001 Boehringer Ingelheim Investigational Site

Kelantan, , Malaysia

1218.65.63001 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

1218.65.63002 Boehringer Ingelheim Investigational Site

San Juan City, , Philippines

Countries

China; Malaysia; Philippines

Other Identifiers

1218.65

Identifier Type: -

Identifier Source: org_study_id