Phase 2
Completed N=302
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT00328172 ↗Enrolled (actual)
302
Serious AEs
1.7%
Results posted
Jun 2011
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12 — 0.18; 0.04; -0.24; -0.28 percent — p=0.3271
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12 |
0.18; 0.04; -0.24; -0.28; -0.68 | 0.3271 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 |
4.24; 6.69; -15.2; -9.09; -30.1 | 0.7027 |
| SECONDARY Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks |
6.3; 10.5; 7.3; 11.1; 26.2; 93.7 | 0.413 |
Eligibility Criteria
Inclusion criteria
- Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
- Diagnosis of Type 2 diabetes with duration of at least 3 months
- Glycosylated haemoglobin A1 (HbA1c) of:
7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
- HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
- Age >=21 and =25.0 and 240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
- Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
- are not surgically sterile,
- or 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, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
- Intolerance of metformin
Data sourced from ClinicalTrials.gov (NCT00328172). 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.