Phase 3
Completed N=299
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control
Source: ClinicalTrials.gov NCT01214239 ↗Enrolled (actual)
299
Serious AEs
1.0%
Results posted
Jul 2013
Primary outcomePrimary: HbA1c Change From Baseline at Week 24 — -0.18; -0.68 % of HbA1c — p=<0.0001
Summary
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment in monotherapy in patients with type 2 diabetes and insufficient glycaemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline at Week 24 |
-0.18; -0.68 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 6 |
-0.072; -0.454 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 12 |
-0.108; -0.609 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 18 |
-0.159; -0.670 | <0.0001 sig |
| SECONDARY HbA1c Change From Baseline at Week 24 in the Subset of Chinese Patients |
-0.23; -0.69 | 0.0001 sig |
| SECONDARY FPG Change From Baseline at Week 6 |
-0.8; -12.0 | 0.0003 sig |
| SECONDARY FPG Change From Baseline at Week 12 |
-2.1; -11.0 | 0.0086 sig |
| SECONDARY FPG Change From Baseline at Week 18 |
-1.0; -10.5 | 0.0135 sig |
| SECONDARY FPG Change From Baseline at Week 24 |
1.5; -8.1 | 0.0113 sig |
| SECONDARY Number of Patients With HbA1c < 7.0% |
26; 94 | — |
| SECONDARY Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%. |
23; 80 | 0.0021 sig |
| SECONDARY Number of Patients With HbA1c < 6.5% |
12; 38 | — |
| SECONDARY Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%. |
11; 36 | 0.2500 |
| SECONDARY Number With HbA1c at Least Lowering 0.5% |
43; 128 | 0.0005 sig |
Eligibility Criteria
Inclusion criteria
- Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment naive or treated with one antidiabetic medication. Antidiabetic therapy has to be unchanged for 6 weeks prior to the informed consent
- Diagnosis of type 2 diabetes prior to informed consent
- Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
For patients undergoing wash out of previous medication: HbA1c =7.0to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
- Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
- Age = 18 and 240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day)
- Known hypersensitivity or allergy to the investigational product or its excipients
- Treatment with more than one antidiabetic drug within 6 weeks prior to informed consent
- Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
- Treatment with Glucagon-like peptide 1(GLP-1) analogues (e.g. exenatide) , Dipeptidyl-Peptidase 4(DPP-IV) inhibitor 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 (last menstruation = 1 year prior to informed consent) 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. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
- 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 (serum creatinine =1.5 mg/dl as determined at Visit 1a)
- Dehydration by clinical judgement of the investigator
- Unstable or acute congestive heart failure
- Acute or chronic metabolic acidosis (present in patient history)
- Hereditary galactose intolerance
Data sourced from ClinicalTrials.gov (NCT01214239). 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.