Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Linagliptin

Registration Number: NCT00996658

Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 278

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets once daily
Linagliptin	Linagliptin	Linagliptin tablets once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks	baseline, 24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks	baseline, 6 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks	baseline, 12 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks	baseline, 18 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks	24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks	24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks	24 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks	baseline, 24 weeks	Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24
Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks	baseline, 6 weeks	Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks	baseline, 12 weeks	Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12
Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks	baseline, 18 weeks	Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18

Trial Locations

Locations (52): 1218.61.01028 Boehringer Ingelheim Investigational Site
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Escondido, California, United States
1218.61.01014 Boehringer Ingelheim Investigational Site
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Greenbrae, California, United States
1218.61.01015 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
1218.61.01042 Boehringer Ingelheim Investigational Site
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Paramount, California, United States
1218.61.01046 Boehringer Ingelheim Investigational Site
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Poway, California, United States
1218.61.01044 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
1218.61.01009 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
1218.61.01049 Boehringer Ingelheim Investigational Site
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Lawrenceville, Georgia, United States
1218.61.01008 Boehringer Ingelheim Investigational Site
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Roswell, Georgia, United States
1218.61.01040 Boehringer Ingelheim Investigational Site
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Meridian, Idaho, United States
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1218.61.01028 Boehringer Ingelheim Investigational Site
🇺🇸Escondido, California, United States