Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00600626
First received: January 14, 2008
Last updated: June 15, 2012
Last verified: June 2012
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Purpose
This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: biphasic insulin aspart Drug: insulin NPH Drug: insulin aspart |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- HbA1c [ Time Frame: after 4 months of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 8-point blood glucose profile [ Designated as safety issue: No ]
- incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
- safety profiles [ Designated as safety issue: No ]
- changes in body weight and vital signs [ Designated as safety issue: No ]
| Enrollment: | 394 |
| Study Start Date: | January 2004 |
| Study Completion Date: | July 2004 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes
- Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
- HbA1c between 8.0-10.5%
- Body mass index (BMI) below 35.0 kg/m2
- Able and willing to perform self-monitoring of blood glucose
Exclusion Criteria:
- Total daily insulin dose of 1.80 IU/kg or more
- Known or suspected allergy to trial product or related products
- Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600626
Locations
| Croatia | |
| Zagreb, Croatia, 10 000 | |
| France | |
| Lille, France, 59037 | |
| Germany | |
| Neuss, Germany, 41460 | |
| Hong Kong | |
| Hong Kong, Hong Kong | |
| Malaysia | |
| Cheras, Malaysia, 56000 | |
| Netherlands | |
| Beverwijk, Netherlands, 1942 LE | |
| Poland | |
| Lodz, Poland, 90-030 | |
| Romania | |
| Timisoara, Romania, 300736 | |
| Russian Federation | |
| Saint-Petersburg, Russian Federation, 194354 | |
| Singapore | |
| Singapore, Singapore, 119074 | |
| Spain | |
| Sevilla, Spain, 41009 | |
| Sweden | |
| Lund, Sweden, 221 85 | |
| United Kingdom | |
| York, United Kingdom, YO3 7HE | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Plamen Kozlovski | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00600626 History of Changes |
| Other Study ID Numbers: | BIASP-1486 |
| Study First Received: | January 14, 2008 |
| Last Updated: | June 15, 2012 |
| Health Authority: | Croatia: Ministry of Health and Social Care France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hong Kong: Department of Health Malaysia: Ministry of Health Netherlands: Dutch Health Care Inspectorate Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials Romania: State Institute for Drug Control Russia: Federal Service for Control of Health Care and Social Development Singapore: Health Sciences Authority Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin Insulin, NPH Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013