Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00611884
First received: January 29, 2008
Last updated: September 22, 2011
Last verified: September 2011
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Purpose
This trial is conducted in Africa, Asia and North America.
The aim of the trial is to compare two NN1250 formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: insulin glargine Drug: metformin Drug: NN1250 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy Comparison of Two NN1250 Formulations and Insulin Glargine All in Combination With Metformin in Insulin Naive Subjects With Type 2 Diabetes, Measured by HbA1c After 16 Weeks of Treatment |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- HbA1c [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plasma glucose profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
- Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
- Frequency and severity of adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
- Laboratory safety parameters [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
- Physical examination and vital signs [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
| Enrollment: | 246 |
| Study Start Date: | January 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: metformin
Tablets, 1500-2000 mg/day
Drug: NN1250
Formulation 1: Treat-to-target dose titration scheme, s.c. injection, once daily
|
| Experimental: B |
Drug: metformin
Tablets, 1500-2000 mg/day
Drug: NN1250
Formulation 2: Treat-to-target dose titration scheme, s.c. injection, once daily
|
| Experimental: C |
Drug: metformin
Tablets, 1500-2000 mg/day
Drug: NN1250
Formulation 1: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
|
| Active Comparator: D |
Drug: insulin glargine
Treat-to-target dose titration scheme, s.c. injection.
Drug: metformin
Tablets, 1500-2000 mg/day
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Insulin naive type 2 subjects for at least 3 months
- Treatment with a stable dosing of maximally tolerated dose or at least half maximally allowed dose of one or two OADs for at least 2 months
- HbA1c 7.0-11.0% (both inclusive)
- Body mass index (BMI) 25-42 kg/m2 (both inclusive)
Exclusion Criteria:
- Metformin contraindication according to local practice
- Treatment with thiazolidinedione (TZD) within the last 3 months prior to screening
- Any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) 3 months prior to randomisation
- Any disease or condition which according to the investigator would interfere with the trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611884
Locations
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Los Angeles, California, United States, 90057 | |
| Novo Nordisk Clinical Trial Call Center | |
| Redlands, California, United States, 92374 | |
| Novo Nordisk Clinical Trial Call Center | |
| Spring Valley, California, United States, 91978 | |
| United States, Florida | |
| Novo Nordisk Clinical Trial Call Center | |
| Jacksonville, Florida, United States, 32204 | |
| United States, Idaho | |
| Novo Nordisk Clinical Trial Call Center | |
| Idaho Falls, Idaho, United States, 83404-7542 | |
| United States, Illinois | |
| Novo Nordisk Clinical Trial Call Center | |
| Chicago, Illinois, United States, 60616 | |
| Novo Nordisk Clinical Trial Call Center | |
| Chicago, Illinois, United States, 60607 | |
| Novo Nordisk Clinical Trial Call Center | |
| Springfield, Illinois, United States, 62704 | |
| United States, North Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Greensboro, North Carolina, United States, 27401-1211 | |
| United States, Oregon | |
| Novo Nordisk Clinical Trial Call Center | |
| Medford, Oregon, United States, 97504 | |
| United States, South Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Simpsonville, South Carolina, United States, 29681 | |
| United States, Tennessee | |
| Novo Nordisk Clinical Trial Call Center | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| Dallas, Texas, United States, 75230 | |
| Novo Nordisk Clinical Trial Call Center | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Novo Nordisk Clinical Trial Call Center | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Novo Nordisk Clinical Trial Call Center | |
| Renton, Washington, United States, 98057 | |
| United States, Wisconsin | |
| Novo Nordisk Clinical Trial Call Center | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Canada | |
| Etobicoke, Canada, M9R 4E1 | |
| India | |
| Vellore, India, 632004 | |
| South Africa | |
| Johannesburg, Gauteng, South Africa, 2001 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Benedikte J. Lertoft, DVM | Novo Nordisk |
More Information
Additional Information:
No publications provided by Novo Nordisk
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT00611884 History of Changes |
| Other Study ID Numbers: | NN1250-1836, 2007-002475-13 |
| Study First Received: | January 29, 2008 |
| Last Updated: | September 22, 2011 |
| Health Authority: | India: Ministry of Health South Africa: Medicines Control Council United States: Institutional Review Board Canada: The Biologics and Genetic Therapies Directorate (BGTD) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine |
Insulin Metformin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013