Phase 3
Completed N=1,261
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00954447 ↗Enrolled (actual)
1,261
Serious AEs
13.5%
Results posted
Sep 2012
Primary outcomePrimary: Change From Baseline in HbA1c After 24 Weeks — 0.07; -0.58 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 during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c After 24 Weeks |
0.07; -0.58 | <0.0001 sig |
| SECONDARY Number of Patients With HbA1c < 7.0 Percent |
56; 134; 44; 109 | <0.0001 sig |
| SECONDARY Number of Patients Lowering HbA1c by at Least 0.5 Percent |
137; 333; 104; 231 | — |
| SECONDARY Change From Baseline in HbA1c by Visit at Week 6 |
0.00; -0.45 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c by Visit at Week 12 |
0.02; -0.59 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c by Visit at Week 18 |
0.03; -0.64 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c by Visit at Week 32 |
0.01; -0.56 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c by Visit at Week 40 |
0.05; -0.50 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c by Visit at Week 52 |
0.05; -0.48 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment |
4.52; -7.09 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment |
0.63; -2.55 | — |
| SECONDARY Change From Baseline in FPG |
2.97; -5.29; -0.33; -7.59; 2.10; -3.30 | — |
| SECONDARY Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment |
4.18; 2.60 | 0.0029 sig |
| SECONDARY Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment |
0.03; -0.01; 0.10; -0.50 | — |
| SECONDARY Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment |
9.31; -3.78; -17.80; -11.00; -1.71; -3.26 | — |
Eligibility Criteria
Inclusion criteria
- Diabetes type 2, detectable C-peptide, HbA1c 7-10%
- Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2
Exclusion criteria
- Uncontrolled hyperglycemia during Run-in
- Myocardial infarction, stroke or TIA within 3 months prior to informed consent
- Liver impairment; gastric surgery; medical history of cancer in last 5 years
- Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
- Unsufficient birth control, pregnancy and nursing
Data sourced from ClinicalTrials.gov (NCT00954447). 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.