Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
Overview[ - collapse ][ - ]
| Purpose | This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA). |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: NNC 90-1170 Drug: metformin |
| Phase | Phase 2 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT01511198 |
| First Received | January 12, 2012 |
| Last Updated | January 23, 2012 |
| Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 12, 2012 |
|---|---|
| Last Updated Date | January 23, 2012 |
| Start Date | February 2001 |
| Estimated Primary Completion Date | October 2001 |
| Current Primary Outcome Measures | Body weight [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent |
|---|---|
| Official Title | NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes |
| Brief Summary | This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA). |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: NNC 90-1170 Injected subcutaneously once daily Drug: metformin 1000 mg twice daily, administered orally |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 223 |
| Estimated Completion Date | October 2001 |
| Estimated Primary Completion Date | October 2001 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetic - Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed - Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive) - HbA1c maximum 10% based on analysis from central laboratory Exclusion Criteria: - Cardiac problems - Uncontrolled treated/untreated hypertension - Proliferative retinopathy or known autonomic neuropathy - Recurrent severe hypoglycemia as judged by the investigator - Known or suspected allergy to trial product or related products - Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed - Known or suspected abuse of alcohol or narcotics - Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness - TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL - Type 1 or other specific causes of diabetes |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01511198 |
|---|---|
| Other Study ID Numbers | NN2211-2072 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Lene Nielsen, DDS Novo Nordisk A/S |
| Verification Date | January 2012 |
Locations[ + expand ][ + ]
| Novo Nordisk Clinical Trial Call Center | Birmingham, Alabama, United States, 35205 |
|---|---|
| Novo Nordisk Clinical Trial Call Center | Tucson, Arizona, United States, 85719 |
| Novo Nordisk Clinical Trial Call Center | Carlisle, Arkansas, United States, 72024 |
| Novo Nordisk Clinical Trial Call Center | Jonesboro, Arkansas, United States, 72401 |
| Novo Nordisk Clinical Trial Call Center | Alhambra, California, United States, 91801 |
| Novo Nordisk Clinical Trial Call Center | Mission Viejo, California, United States, 92691 |
| Novo Nordisk Clinical Trial Call Center | Walnut Creek, California, United States, 94598 |
| Novo Nordisk Clinical Trial Call Center | Trumbull, Connecticut, United States, 06611 |
| Novo Nordisk Clinical Trial Call Center | Jacksonville, Florida, United States, 32216 |
| Novo Nordisk Clinical Trial Call Center | Miami, Florida, United States, 33156 |
| Novo Nordisk Clinical Trial Call Center | Ocala, Florida, United States, 34471 |
| Novo Nordisk Clinical Trial Call Center | Pembroke Pines, Florida, United States, 33024 |
| Novo Nordisk Clinical Trial Call Center | St. Petersburg, Florida, United States, 33702 |
| Novo Nordisk Clinical Trial Call Center | Titusville, Florida, United States, 32796 |
| Novo Nordisk Clinical Trial Call Center | West Palm Beach, Florida, United States, 33401 |
| Novo Nordisk Clinical Trial Call Center | Chicago, Illinois, United States, 60607 |
| Novo Nordisk Clinical Trial Call Center | Springfield, Illinois, United States, 62704 |
| Novo Nordisk Clinical Trial Call Center | Duluth, Minnesota, United States, 55805 |
| Novo Nordisk Clinical Trial Call Center | St. Louis, Missouri, United States, 63117 |
| Novo Nordisk Clinical Trial Call Center | St. Louis, Missouri, United States, 63141 |
| Novo Nordisk Clinical Trial Call Center | North Plainfield, New Jersey, United States, 07060 |
| Novo Nordisk Clinical Trial Call Center | Charlotte, North Carolina, United States, 28277 |
| Novo Nordisk Clinical Trial Call Center | Durham, North Carolina, United States, 27710 |
| Novo Nordisk Clinical Trial Call Center | Oklahoma City, Oklahoma, United States, 73104 |
| Novo Nordisk Clinical Trial Call Center | Chattanooga, Tennessee, United States, 37404 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75230 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75246 |
| Novo Nordisk Clinical Trial Call Center | San Antonio, Texas, United States, 78209 |
| Novo Nordisk Clinical Trial Call Center | San Antonio, Texas, United States, 78229 |
| Novo Nordisk Clinical Trial Call Center | Salt Lake City, Utah, United States, 84132 |
| Novo Nordisk Clinical Trial Call Center | Richmond, Virginia, United States, 23294 |
| Novo Nordisk Clinical Trial Call Center | Edmonds, Washington, United States, 98026 |
| Novo Nordisk Clinical Trial Call Center | Edmonds, Washington, United States, 98026-7610 |
| Novo Nordisk Clinical Trial Call Center | Renton, Washington, United States, 98057 |
| Novo Nordisk Clinical Trial Call Center | Tacoma, Washington, United States, 98405 |
| Novo Nordisk Clinical Trial Call Center | Charleston, West Virginia, United States, 25301 |