Phase 3
Completed N=278
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
Source: ClinicalTrials.gov NCT00996658 ↗Enrolled (actual)
278
Serious AEs
2.6%
Results posted
Mar 2013
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks — -0.27; -0.84 Percentage — p=< 0.0001
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks |
-0.27; -0.84 | < 0.0001 sig |
| SECONDARY Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks |
-0.19; -0.60 | < 0.0001 sig |
| SECONDARY Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks |
-0.28; -0.82 | < 0.0001 sig |
| SECONDARY Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks |
-0.37; -0.91 | < 0.0001 sig |
| SECONDARY Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks |
12; 57; 75; 118; 0; 1 | 0.0033 sig |
| SECONDARY Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks |
5; 34; 84; 143; 0; 1 | 0.0074 sig |
| SECONDARY Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks |
44; 117; 45; 61; 0; 1 | 0.0071 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks |
0.1; -10.3 | 0.0280 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks |
12.4; -3.3 | 0.0006 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks |
3.8; -7.1 | 0.0210 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks |
-2.4; -8.6 | 0.2137 |
Eligibility Criteria
Inclusion criteria
- Diagnosis of diabetes mellitus prior to informed consent
- Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
- Glycosylated haemoglobin A1 >= 7.5% and <= 10%
- Age between 18 and less than 80
- - Body Mass index less or equal to 45
Exclusion criteria
- Uncontrolled hyperglycaemia during run in period
- Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
- Impaired hepatic function
- Gastric by pass surgery
- Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
- Treatment with anti-obesity drugs
- Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Premenopausal 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 during the trial
Data sourced from ClinicalTrials.gov (NCT00996658). 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.