BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00749190
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2009-10
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
3. HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
4. HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
5. Age >=18 and <80years
6. Body Mass Index (BMI) <=40 kg/m2
7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
2. Impaired hepatic function
3. Renal insufficiency or impaired renal function
4. Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
5. Chronic or clinically relevant acute infections
6. Current or chronic urogenital tract infection
7. History of clinically relevant allergy/hypersensitivity
8. Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
9. Treatment with anti-obesity drugs within 3 months prior to informed consent
10. Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
11. Alcohol abuse or drug abuse
12. Treatment with an investigational drug within 2 months prior to informed consent
13. Women of child-bearing potential who are nursing or pregnant, or who 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 periodic pregnancy testing during participation in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c After 12 Weeks of Treatment	Baseline and 12 weeks	Change from baseline in HbA1c after 12 weeks of treatment.; In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Secondary Outcome Measures

Name	Time	Method
Change of Body Weight After 12 Weeks of Treatment	Baseline and 12 weeks	Results for change of body weight after 12 weeks of treatment based on ANCOVA.
Trough Concentrations of Empagliflozin in Plasma	Days 28, 56 and 84	(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.
Change of FPG From Baseline After 12 Weeks of Treatment	Baseline and 12 weeks	Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.; In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
Change of HbA1c From Baseline Over Time	Baseline and weeks 4, 8 and 12	Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.
Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment	Baseline and 12 weeks	Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment	Baseline and 12 weeks	Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)	Baseline and 12 weeks	Results for change of FPI from baseline at week 12 based on ANCOVA
Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)	Baseline and 12 weeks	HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.
Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)	Baseline and 12 weeks	HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.

Trial Locations

Locations (116)

1245.10.10026 Boehringer Ingelheim Investigational Site; 🇺🇸 Chula Vista, California, United States

1245.10.10001 Boehringer Ingelheim Investigational Site; 🇺🇸 Mission Viejo, California, United States

1245.10.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Pasadena, California, United States

1245.10.10028 Boehringer Ingelheim Investigational Site; 🇺🇸 Spring Valley, California, United States

1245.10.10027 Boehringer Ingelheim Investigational Site; 🇺🇸 Walnut Creek, California, United States

1245.10.10004 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwarter, Florida, United States

1245.10.10021 Boehringer Ingelheim Investigational Site; 🇺🇸 Melbourne, Florida, United States

1245.10.10005 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1245.10.10019 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1245.10.10024 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Cloud, Florida, United States

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