None listed
Conditions
Interventions
Group 1 Type of group
Linagliptin 5 mg / once daily orally
Group name:Group 2 Type of group
Placebo once a day orally
Sponsors
Boehringer Ingelheim,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Diagnosis of type 2 diabetes mellitus, confirmed by a measurable C-peptide level at Visit 1 (screening) • Pre-treatment with basal insulin alone or basal insulin in combination with Metformin or/and Pioglitazone. Acceptable basal insulins could be insulin glargin, insulin detemir or NPH (neutral protamin hagedorn) insulin with duration of action up to 24 h. This antidiabetic therapy has to be unchanged for at least 12 weeks prior to Visit 3 (randomisation). • HbA1c =7.0 % and 18 years at Visit 1 • BMI < 45 kg/m2 (Body Mass Index) at Visit 1 • Signed and dated written informed consent by date of Visit 1
Exclusion criteria
Exclusion criteria: • Uncontrolled fasting hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after fast of at least 6 hours during placebo run-in, confirmed by a second measurement on a following day. • Myocardial infarction, stroke or TIA within 3 months prior to informed consent. • Impaired hepatic function at Visit 1. • Gastric bypass surgery. • Medical history of cancer (except for basal cell carcinoma) with respective treatment in the last 5 years prior to screening. • Known hypersensitivity or allergy to the investigational product or its recipients. • Any contraindications to metformin according to the local label for those patients that enter the study with metformin therapy. • Any contraindications to Pioglitazone according to the local label for those patients that enter the study with pioglitazone therapy. • Treatment with rosiglitazone, sulfonylurea, GLP-1 analogues or DPP-IV inhibitors within 3 months prior to informed consent. • Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent. • Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation. • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD) Measure:Change From Baseline in HbA1c After 24 Weeks Timepoints:Baseline and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Measure:Change From Baseline in HbA1c by Visit at Week 6 Timepoints:Baseline and 6 weeks ; Outcome name:Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Measure:Change From Baseline in HbA1c by Visit at Week 12, 18, 32, 40, 52 Timepoints:Week 12, 18, 32, 40, 52 ; Outcome name:Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs Measure:Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment Timepoints:Baseline and 24 weeks | — |
Countries
Czech Republic, Finland, Germany, Italy, Netherlands, Peru, Slovakia, Spain, Sweden
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed