Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00613951
First received: January 30, 2008
Last updated: November 9, 2009
Last verified: November 2009
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Purpose
This trial is conducted in Europe. The aim of the trial is to compare two NN5401 formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: NN5401 Drug: biphasic insulin aspart Drug: metformin |
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 NN5401 Formulations and Biphasic Insulin Aspart 30, 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: No ]
| Enrollment: | 182 |
| 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: NN5401
Formulation 1: Treat-to-target dose titration scheme, injection s.c., twice daily
Drug: metformin
Tablets, 1500-2000 mg/daily
|
| Experimental: B |
Drug: NN5401
Formulation 2: Treat-to-target dose titration scheme, injection s.c., twice daily
Drug: metformin
Tablets, 1500-2000 mg/daily
|
| Active Comparator: C |
Drug: biphasic insulin aspart
Treat-to-target dose titration scheme, injection s.c., twice daily
Drug: metformin
Tablets, 1500-2000 mg/daily
|
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 7-11% (both inclusive)
- Body mass index (BMI) 25-37 kg/m2 (both inclusive)
Exclusion Criteria:
- Metformin contraindication according to local practice
- Treatment with thiazolidinedione (TZD) within 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: NCT00613951
Locations
| Finland | |
| Lahti, Finland, 15110 | |
| France | |
| Narbonne, France, 11108 | |
| Germany | |
| Riesa, Germany, 01587 | |
| Poland | |
| Warszawa, Mazowieckie, Poland, 02-507 | |
| Spain | |
| Madrid, Spain, 28034 | |
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: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00613951 History of Changes |
| Other Study ID Numbers: | NN5401-1792, EudraCT No: 2007-002462-35 |
| Study First Received: | January 30, 2008 |
| Last Updated: | November 9, 2009 |
| Health Authority: | Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Poland: Ministry of Health Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin Metformin Insulin, NPH Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013