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Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Linagliptin
Drug: Glimepiride
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00309608
2005-004597-24 (EudraCT Number)
1218.6

Details and patient eligibility

About

The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

Enrollment

333 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion_Criteria:

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
  • HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
  • HbA1c 7.5 10.0% at screening for patients treated with metformin alone
  • HbA1c 7.5 10.0% at beginning of the placebo run-in phase
  • Age > 21 and < 75 years
  • MI > 25 and < 40 kg/m2 (Body Mass Index)

Exclusion criteria

Exclusion_Criteria:

  • Clinically relevant cardiovascular disease
  • Impaired hepatic function
  • Renal insufficiency or impaired renal function
  • Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  • Treatment with insulin within 3 months prior to screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

333 participants in 5 patient groups, including a placebo group

Linagliptin low dose
Experimental group
Description:
Patients receive Linagliptin low dose tablets once daily
Treatment:
Drug: Linagliptin
Drug: Linagliptin
Drug: Linagliptin
Linagliptin medium dose
Experimental group
Description:
Patients receive Linagliptin medium dose tablets once daily
Treatment:
Drug: Linagliptin
Drug: Linagliptin
Drug: Linagliptin
Linagliptin high dose
Experimental group
Description:
Patients receive Linagliptin high dose tablets once daily
Treatment:
Drug: Linagliptin
Drug: Linagliptin
Drug: Linagliptin
Placebo
Placebo Comparator group
Description:
Patients receive tablets identical to those containing Linagliptin low, medium and high dose
Treatment:
Drug: Placebo
Glimepiride
Active Comparator group
Description:
Patients receive Glimepiride tablets once daily
Treatment:
Drug: Glimepiride

Trial contacts and locations

48

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Data sourced from clinicaltrials.gov

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