Diabetes Mellitus, Type 2 Clinical Trial
Official 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
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
| Status | Completed |
| Enrollment | 494 |
| Est. completion date | |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | 1245.33.45006 Boehringer Ingelheim Investigational Site | Aalborg | |
| Denmark | 1245.33.45001 Boehringer Ingelheim Investigational Site | Aarhus C | |
| Denmark | 1245.33.45011 Boehringer Ingelheim Investigational Site | Aarhus C | |
| Denmark | 1245.33.45013 Boehringer Ingelheim Investigational Site | Aarhus C | |
| Denmark | 1245.33.45004 Boehringer Ingelheim Investigational Site | Gentofte | |
| Denmark | 1245.33.45008 Boehringer Ingelheim Investigational Site | Hillerød | |
| Denmark | 1245.33.45002 Boehringer Ingelheim Investigational Site | Hvidovre | |
| Denmark | 1245.33.45003 Boehringer Ingelheim Investigational Site | København NV | |
| France | 1245.33.3301A Boehringer Ingelheim Investigational Site | Bondy Cedex | |
| France | 1245.33.3302A Boehringer Ingelheim Investigational Site | Corbeil Essonnes | |
| France | 1245.33.3305A Boehringer Ingelheim Investigational Site | La Rochelle Cedex 1 | |
| France | 1245.33.3306A Boehringer Ingelheim Investigational Site | Marseille | |
| France | 1245.33.3308A Boehringer Ingelheim Investigational Site | Montbrison | |
| France | 1245.33.3309A Boehringer Ingelheim Investigational Site | Nanterre Cedex | |
| France | 1245.33.3310A Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1245.33.3304A Boehringer Ingelheim Investigational Site | Narbonne Cedex | |
| France | 1245.33.3303A Boehringer Ingelheim Investigational Site | Saint Mandé | |
| Ireland | 1245.33.35302 Boehringer Ingelheim Investigational Site | Dublin | |
| Ireland | 1245.33.35303 Boehringer Ingelheim Investigational Site | Dublin | |
| Ireland | 1245.33.35304 Boehringer Ingelheim Investigational Site | Dublin | |
| Korea, Republic of | 1245.33.82008 Boehringer Ingelheim Investigational Site | Daejeon | |
| Korea, Republic of | 1245.33.82007 Boehringer Ingelheim Investigational Site | Gwangju | |
| Korea, Republic of | 1245.33.82001 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.33.82003 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.33.82004 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.33.82005 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.33.82006 Boehringer Ingelheim Investigational Site | Wonju | |
| Korea, Republic of | 1245.33.82002 Boehringer Ingelheim Investigational Site | Yangsan | |
| Portugal | 1245.33.35104 Boehringer Ingelheim Investigational Site | Aveiro | |
| Portugal | 1245.33.35101 Boehringer Ingelheim Investigational Site | Coimbra | |
| Portugal | 1245.33.35102 Boehringer Ingelheim Investigational Site | Lisboa | |
| Portugal | 1245.33.35106 Boehringer Ingelheim Investigational Site | Lisboa | |
| Portugal | 1245.33.35107 Boehringer Ingelheim Investigational Site | Lisboa | |
| United Kingdom | 1245.33.44001 Boehringer Ingelheim Investigational Site | Bath | |
| United Kingdom | 1245.33.44003 Boehringer Ingelheim Investigational Site | Birmingham | |
| United Kingdom | 1245.33.44006 Boehringer Ingelheim Investigational Site | Blackburn | |
| United Kingdom | 1245.33.44005 Boehringer Ingelheim Investigational Site | Dorking | |
| United Kingdom | 1245.33.44009 Boehringer Ingelheim Investigational Site | Headington | |
| United Kingdom | 1245.33.44008 Boehringer Ingelheim Investigational Site | Leicester | |
| United Kingdom | 1245.33.44004 Boehringer Ingelheim Investigational Site | Liverpool | |
| United Kingdom | 1245.33.44007 Boehringer Ingelheim Investigational Site | Wembley | |
| United Kingdom | 1245.33.44002 Boehringer Ingelheim Investigational Site | Whitstable | |
| United Kingdom | 1245.33.44010 Boehringer Ingelheim Investigational Site | Wymondham | |
| United States | 1245.33.01018 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania |
| United States | 1245.33.01027 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 1245.33.01014 Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | 1245.33.01046 Boehringer Ingelheim Investigational Site | Bradednton | Florida |
| United States | 1245.33.01050 Boehringer Ingelheim Investigational Site | Brooksville | Florida |
| United States | 1245.33.01041 Boehringer Ingelheim Investigational Site | Carlisle | Pennsylvania |
| United States | 1245.33.01020 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1245.33.01044 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1245.33.01059 Boehringer Ingelheim Investigational Site | Chiefland | Florida |
| United States | 1245.33.01025 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 1245.33.01028 Boehringer Ingelheim Investigational Site | Clearwater | Florida |
| United States | 1245.33.01001 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1245.33.01023 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1245.33.01030 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1245.33.01040 Boehringer Ingelheim Investigational Site | Decatur | Georgia |
| United States | 1245.33.01054 Boehringer Ingelheim Investigational Site | Denver | Colorado |
| United States | 1245.33.01024 Boehringer Ingelheim Investigational Site | Des Moines | Iowa |
| United States | 1245.33.01045 Boehringer Ingelheim Investigational Site | Eugene | Oregon |
| United States | 1245.33.01010 Boehringer Ingelheim Investigational Site | Federal Way | Washington |
| United States | 1245.33.01029 Boehringer Ingelheim Investigational Site | Fleming Island | Florida |
| United States | 1245.33.01060 Boehringer Ingelheim Investigational Site | Fresno | California |
| United States | 1245.33.01007 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina |
| United States | 1245.33.01004 Boehringer Ingelheim Investigational Site | Greer | South Carolina |
| United States | 1245.33.01048 Boehringer Ingelheim Investigational Site | Hollywood | Florida |
| United States | 1245.33.01006 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1245.33.01011 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1245.33.01003 Boehringer Ingelheim Investigational Site | Jacksonville | North Carolina |
| United States | 1245.33.01032 Boehringer Ingelheim Investigational Site | Kansas City | Missouri |
| United States | 1245.33.01058 Boehringer Ingelheim Investigational Site | Kingsport | Tennessee |
| United States | 1245.33.01042 Boehringer Ingelheim Investigational Site | Landsdale | Pennsylvania |
| United States | 1245.33.01043 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada |
| United States | 1245.33.01062 Boehringer Ingelheim Investigational Site | Lawrenceville | Georgia |
| United States | 1245.33.01013 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1245.33.01008 Boehringer Ingelheim Investigational Site | Los Gatos | California |
| United States | 1245.33.01037 Boehringer Ingelheim Investigational Site | Memphis | Tennessee |
| United States | 1245.33.01061 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin |
| United States | 1245.33.01036 Boehringer Ingelheim Investigational Site | Mt. Pleasant | South Carolina |
| United States | 1245.33.01019 Boehringer Ingelheim Investigational Site | National City | California |
| United States | 1245.33.01051 Boehringer Ingelheim Investigational Site | New Hartford | New York |
| United States | 1245.33.01033 Boehringer Ingelheim Investigational Site | New Port Richey | Florida |
| United States | 1245.33.01015 Boehringer Ingelheim Investigational Site | Norfolk | Virginia |
| United States | 1245.33.01056 Boehringer Ingelheim Investigational Site | Olive Branch | Mississippi |
| United States | 1245.33.01017 Boehringer Ingelheim Investigational Site | Omaha | Nebraska |
| United States | 1245.33.01055 Boehringer Ingelheim Investigational Site | Paramount | California |
| United States | 1245.33.01047 Boehringer Ingelheim Investigational Site | Phoenix | Arizona |
| United States | 1245.33.01009 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
| United States | 1245.33.01016 Boehringer Ingelheim Investigational Site | Salisbury | North Carolina |
| United States | 1245.33.01049 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah |
| United States | 1245.33.01012 Boehringer Ingelheim Investigational Site | Santa Ana | California |
| United States | 1245.33.01035 Boehringer Ingelheim Investigational Site | Seneca | South Carolina |
| United States | 1245.33.01022 Boehringer Ingelheim Investigational Site | St. Louis | Maryland |
| United States | 1245.33.01005 Boehringer Ingelheim Investigational Site | Statesville | North Carolina |
| United States | 1245.33.01002 Boehringer Ingelheim Investigational Site | Sugar Land | Texas |
| United States | 1245.33.01031 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma |
| United States | 1245.33.01038 Boehringer Ingelheim Investigational Site | Wilmington | North Carolina |
| United States | 1245.33.01026 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim | Eli Lilly and Company |
United States, Denmark, France, Ireland, Korea, Republic of, Portugal, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Confirmed Hypoglycemic Events | Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value =70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as 'Hypoglycaemic event' in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia). | During the course of the study (82 weeks) | No |
| Primary | Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment | Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment | Baseline and 18 weeks | No |
| Secondary | Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment | Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment | Baseline and 18, 54 and 78 weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment | Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment | Baseline, 18, 54 and 78 weeks | No |
| Secondary | Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment | Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment | Baseline, 18, 54 and 78 weeks | No |
| Secondary | Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment | Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment | Baseline, 54 and 78 weeks | No |
| Secondary | Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment | Change from baseline in body weight after 18, 54 and 78 weeks of treatment | Baseline, 18, 54, 78 weeks | No |
| Secondary | Change From Baseline in Body Weight at Follow-up | Change from baseline in body weight at follow up (82 weeks) | Baseline and 82 weeks | No |
| Secondary | Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment | Change from baseline in HbA1c after 54 and 78 weeks of treatment | Baseline, 54 and 78 weeks | No |
| Secondary | 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 | 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 | Baseline, 18, 54 and 78 weeks | No |
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