Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00604396
First received: January 17, 2008
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin NPH
Phase 3

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 of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose [ Designated as safety issue: No ]
  • Within-subject variation [ Designated as safety issue: No ]
  • Incidence of total hypoglycaemic episodes [ Designated as safety issue: Yes ]
  • Body weight [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: Yes ]
  • Insulin antibodies [ Designated as safety issue: No ]

Enrollment: 477
Study Start Date: March 2003
Study Completion Date: January 2004
Primary Completion Date: January 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 for at least 12 months since diagnosis
  • Insulin naive subjects
  • OAD treatment for at least 4 months alone or combined with no more than two OADs
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-10.0%
  • Able and willing to use twice a day injections for the entire trial period

Exclusion Criteria:

  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 6 months
  • Acute insulin treatment for longer than 7 days in a row within the last 6 months
  • Secondary diabetes
  • Known maturity onset of diabetes of young (MODY)
  • Known or suspected allergy to trial product or related products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604396

Locations
Belgium
Arlon, Belgium, 6700
Croatia
Rijeka, Croatia, 51 000
Denmark
Hvidovre, Denmark, 2650
France
Nanterre, France, 92014
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Norway
Elverum, Norway, 2408
Poland
Krakow, Poland, 31-261
Russian Federation
Moscow, Russian Federation, 117036
Slovakia
Trencin, Slovakia, 91171
Sweden
Trelleborg, Sweden, 231 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jens Larsen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00604396     History of Changes
Other Study ID Numbers: NN304-1530
Study First Received: January 17, 2008
Last Updated: June 19, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health
Norway: Norwegian Medicines Agency
Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
Russia: Federal Service for Control of Health Care and Social Development
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014