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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01011868
Date of registration: 10/11/2009
Prospective Registration: Yes
Primary sponsor: Boehringer Ingelheim
Public title: Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
Scientific title: A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control
Date of first enrolment: November 2009
Target sample size: 494
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01011868
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Denmark France Ireland Korea, Republic of Portugal United Kingdom United States
Contacts
Name:   Boehringer Ingelheim
Address: 
Telephone:
Email:
Affiliation:  Boehringer Ingelheim
Key inclusion & exclusion criteria

Inclusion criteria:

1. Signed and dated written informed consent by date of Visit 1 in accordance with Good
Clinical Practice (GCP) and local legislation

2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a
stable dose of basal insulin with or without concomitant metformin and / or
sulfonylurea.

3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1
(screening)

4. Suitability for trial participation according to investigator's judgment (evaluating
all alternative treatment options and in consideration of the patient completing the
study)

5. Age > or =18 years at Visit 1 (screening)

6. BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Exclusion criteria:

1. Patients with poorly controlled hyperglycemia

2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on
basal insulin therapy

3. MI, stroke, or TIA within 3 months prior to obtaining informed consent

4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years;
blood dyscrasias

6. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid
hormones, participation in another trial with an investigational drug 7. Pre-menopausal
women on insufficient birth control 8. Alcohol or drug abuse



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Diabetes Mellitus, Type 2
Intervention(s)
Drug: BI 10773 high dose
Drug: BI 10773 low dose
Drug: BI 10773 placebo
Primary Outcome(s)
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment [Time Frame: Baseline and 18 weeks]
Secondary Outcome(s)
Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment [Time Frame: Baseline, 54 and 78 weeks]
Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment [Time Frame: Baseline, 18, 54, 78 weeks]
Change From Baseline in Body Weight at Follow-up [Time Frame: Baseline and 82 weeks]
Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment [Time Frame: Baseline, 18, 54 and 78 weeks]
Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment [Time Frame: Baseline, 54 and 78 weeks]
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment [Time Frame: Baseline and 18, 54 and 78 weeks]
Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment [Time Frame: Baseline, 18, 54 and 78 weeks]
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment [Time Frame: Baseline, 18, 54 and 78 weeks]
Secondary ID(s)
1245.33
2009-013668-38
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Eli Lilly and Company
Ethics review
Results
Results available: Yes
Date Posted: 30/09/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01011868
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