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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 October 2012 |
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Main ID: |
NCT01011868 |
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Date of registration:
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10/11/2009 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
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Scientific title:
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A Phase IIb Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 10773 Administered Orally Once Daily for 78 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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494 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01011868 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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France
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Ireland
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Korea, Republic of
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Portugal
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United Kingdom
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim Pharmaceuticals |
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Key inclusion & exclusion criteria
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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:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: BI 10773 high dose
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Drug: BI 10773 low dose
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Drug: BI 10773 placebo
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Primary Outcome(s)
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Change from baseline in Glycosylated haemoglobin A1c (HbA1c)
[Time Frame: 18 weeks]
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Secondary Outcome(s)
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Change from baseline and percent change from baseline in fasting plasma glucose (FPG)
[Time Frame: 18, 54, 78 weeks]
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Change from baseline in body weight
[Time Frame: 54, 78 and 82 weeks]
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Change from baseline in dose of basal insulin therapy
[Time Frame: 54 and 78 weeks]
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Change from baseline in Glycosylated haemoglobin A1c (HbA1c)
[Time Frame: 54 and 78 weeks]
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Treat to target and relative efficacy response of reduction in HbA1c of at least 0.5%
[Time Frame: 18, 54, 78 weeks]
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Secondary ID(s)
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1245.33
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2009-013668-38
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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