Diabetes Mellitus, Type 2 Clinical Trial
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
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 223 |
| Est. completion date | October 2001 |
| Est. primary completion date | October 2001 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Novo Nordisk Investigational Site | Alhambra | California |
| United States | Novo Nordisk Investigational Site | Carlisle | Arkansas |
| United States | Novo Nordisk Investigational Site | Charleston | West Virginia |
| United States | Novo Nordisk Investigational Site | Charlotte | North Carolina |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Corpus Christi | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Duluth | Minnesota |
| United States | Novo Nordisk Investigational Site | Durham | North Carolina |
| United States | Novo Nordisk Investigational Site | Edmonds | Washington |
| United States | Novo Nordisk Investigational Site | Edmonds | Washington |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jonesboro | Arkansas |
| United States | Novo Nordisk Investigational Site | Melbourne | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Mission Viejo | California |
| United States | Novo Nordisk Investigational Site | North Plainfield | New Jersey |
| United States | Novo Nordisk Investigational Site | Ocala | Florida |
| United States | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma |
| United States | Novo Nordisk Investigational Site | Pembroke Pines | Florida |
| United States | Novo Nordisk Investigational Site | Renton | Washington |
| United States | Novo Nordisk Investigational Site | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | St. Petersburg | Florida |
| United States | Novo Nordisk Investigational Site | Tacoma | Washington |
| United States | Novo Nordisk Investigational Site | Titusville | Florida |
| United States | Novo Nordisk Investigational Site | Trumbull | Connecticut |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Vestavia | Alabama |
| United States | Novo Nordisk Investigational Site | Walnut Creek | California |
| United States | Novo Nordisk Investigational Site | West Palm Beach | Florida |
| United States | Novo Nordisk Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States,
Feinglos MN, Saad MF, Pi-Sunyer FX, An B, Santiago O; Liraglutide Dose-Response Study Group.. Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. Diabet Med. 2005 Aug;22(8):1 — View Citation
Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13- — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Body weight | |||
| Secondary | FPG (fasting plasma glucose) | |||
| Secondary | HbA1c (glycosylated haemoglobin) | |||
| Secondary | Fructosamine | |||
| Secondary | Lipids | |||
| Secondary | Adverse events |
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