Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

Phase 4

Completed

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

• Registration Number: NCT01512979
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-16
• Study First Posted: 2012-01-20
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-04-08
• Results First Submitted QC: 2014-04-08
• Status Verified: 2014-05
• Results First Posted: 2014-05-09
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linagliptin	linagliptin	patients receive linagliptin tablet once daily
linagliptin plus metformin	metformin placebo	patients receive linagliptin tablet once daily and metformin tablets twice daily
linagliptin	metformin placebo	patients receive linagliptin tablet once daily
linagliptin plus metformin	linagliptin	patients receive linagliptin tablet once daily and metformin tablets twice daily
linagliptin plus metformin	metformin	patients receive linagliptin tablet once daily and metformin tablets twice daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c After 24 Weeks	Baseline and 24 weeks	HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment	Baseline and 24 weeks	The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.
Change From Baseline in HbA1c by Visit Over Time	Baseline, 6, 12, 18 and 24 weeks	HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)	Baseline and 24 weeks	The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)	Baseline and 24 weeks	The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment	Baseline and 24 weeks	The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
Change From Baseline in FPG by Visit Over Time	Baseline, 6, 12, 18 and 24 weeks	The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.

Trial Locations

Locations (82)

1218.83.11002 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1218.83.11036 Boehringer Ingelheim Investigational Site; 🇺🇸 Little Rock, Arkansas, United States

1218.83.11011 Boehringer Ingelheim Investigational Site; 🇺🇸 Chino, California, United States

1218.83.11001 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Beach, California, United States

1218.83.11019 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntington Park, California, United States

1218.83.11015 Boehringer Ingelheim Investigational Site; 🇺🇸 Lomita, California, United States

1218.83.11023 Boehringer Ingelheim Investigational Site; 🇺🇸 Norwalk, California, United States

1218.83.11014 Boehringer Ingelheim Investigational Site; 🇺🇸 Roseville, California, United States

1218.83.11031 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

1218.83.11022 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Lauderdale, Florida, United States

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