Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: metformin placebo; Drug: metformin; Drug: linagliptin; Drug: linagliptin placebo

• Registration Number: NCT01438814
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Study Start: 2011-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-02-28
• Results First Submitted QC: 2014-05-02
• Results First Posted: 2014-06-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 689

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linagliptin + metformin	linagliptin	patients to receive linagliptin +metformin QD
metformin	metformin placebo	patients to receive metformin BID
metformin	linagliptin placebo	patients to receive metformin BID
linagliptin + metformin	metformin	patients to receive linagliptin +metformin QD
metformin	metformin	patients to receive metformin BID

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment	Baseline and 14 weeks	Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c.

Secondary Outcome Measures

Name	Time	Method
Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment	14 weeks	Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks
Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks	14 weeks	The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)	14 weeks	The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment).
Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment	14 weeks	Patients could experience multiple events, therefore, multiple answers were possible for each patient.
Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators	14 weeks	The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)	14 weeks	The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment).
Change From Baseline in Body Weight by Visit at Week 14	Baseline and 14 weeks	Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight
Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment	Baseline and 14 weeks	Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.
Change From Baseline in HbA1c Over Time	Baseline, 2 weeks and 8 weeks	Means are adjusted by treatment and continuous baseline HbA1c
Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment	14 weeks	The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment)
Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment	14 weeks	The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c.
Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks	14 weeks	The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).

Trial Locations

Locations (90)

1218.60.90001 Boehringer Ingelheim Investigational Site; 🇧🇩 Dhaka, Bangladesh

1218.60.90002 Boehringer Ingelheim Investigational Site; 🇧🇩 Dhaka, Bangladesh

1218.60.90003 Boehringer Ingelheim Investigational Site; 🇧🇩 Dhaka, Bangladesh

1218.60.32001 Boehringer Ingelheim Investigational Site; 🇧🇪 Genk, Belgium

1218.60.32005 Boehringer Ingelheim Investigational Site; 🇧🇪 Ham, Belgium

1218.60.32002 Boehringer Ingelheim Investigational Site; 🇧🇪 Hasselt, Belgium

1218.60.32004 Boehringer Ingelheim Investigational Site; 🇧🇪 Natoye, Belgium

1218.60.32003 Boehringer Ingelheim Investigational Site; 🇧🇪 Tremelo, Belgium

1218.60.20009 Boehringer Ingelheim Investigational Site; 🇨🇦 Calgary, Alberta, Canada

1218.60.20003 Boehringer Ingelheim Investigational Site; 🇨🇦 Burnaby, British Columbia, Canada

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