Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00612599
First received: January 28, 2008
Last updated: June 15, 2012
Last verified: June 2012
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Purpose
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: biphasic insulin aspart |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Non-obese and Obese With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Area under the serum glucose concentration profile during 24 hours [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacodynamics properties [ Designated as safety issue: No ]
- Pharmacokinetic properties [ Designated as safety issue: No ]
- 8-point self-monitored blood glucose profiles [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: No ]
- Hypoglycaemic episodes [ Designated as safety issue: No ]
| Enrollment: | 75 |
| Study Start Date: | September 2003 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: biphasic insulin aspart
Other Name: BIASP
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes for at least 12 months
- Stable glycaemic control, having been on the existing treatment for at least 1 month
- BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese)
- HbA1c below 9.0%
- Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly
Exclusion Criteria:
- A history of drug abuse or alcohol dependence
- Blood donation within the last 3 months
- Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose
- Severe, uncontrolled hypertension
- Proliferative retinopathy or maculopathy requiring acute treatment
- Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00612599 History of Changes |
| Other Study ID Numbers: | BIASP-1526 |
| Study First Received: | January 28, 2008 |
| Last Updated: | June 15, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin aspart Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013