Phase 3
Completed N=700
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00601250 ↗Enrolled (actual)
700
Serious AEs
3.1%
Results posted
Jun 2011
Primary outcomePrimary: HbA1c Change From Baseline at Week 24 — 0.15; -0.49 Percent — p=<0.0001
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 24 |
0.15; -0.49 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 6 |
0.069; -0.363 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 12 |
0.096; -0.499 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 18 |
0.147; -0.502 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 24 |
10.46; -10.68 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 6 |
4.58; -11.94 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 12 |
3.86; -12.86 | <0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 18 |
10.32; -10.51 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c <7.0% at Week 24. |
9.2; 26.2 | <0.0001 sig |
| SECONDARY Percentage of Patients With HbA1c < 7.0% at Week 24 |
11.4; 28.3 | — |
| SECONDARY Percentage of Patients With HbA1c <6.5% at Week 24 |
2.3; 10.4 | 0.0016 sig |
| SECONDARY Percentage of Patients With HbA1c<6.5% at Week 24 |
3.4; 10.7 | — |
| SECONDARY Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24 |
21.7; 49.7 | <0.0001 sig |
| SECONDARY Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24 |
18.27; -48.86 | <0.0001 sig |
| SECONDARY 2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24 |
10.90; -30.90 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- 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
- Diagnosis of type 2 diabetes prior to informed consent
- Glycosylated haemoglobin A1 (HbA1c)at screening:
For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
- Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
- Age 18 -80 years
- BMI (Body Mass Index) less than 40 kg/m2
- Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation
Exclusion criteria
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
- Impaired hepatic function
- Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
- Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
- Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
- Treatment with insulin within 3 months prior to informed consent
- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
- Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
- Participation in another trial with an investigational drug within 2 months prior to informed consent
- Pre-menopausal women 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.
- Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
- Renal failure or renal impairment
- Unstable or acute congestive heart failure
- Acute or chronic metabolic acidosis (present in patient history)
- Hereditary galactose intolerance
Data sourced from ClinicalTrials.gov (NCT00601250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.