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Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy (INITIATE)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00598793
First received: January 11, 2008
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: insulin glargine
Drug: metformin
Drug: pioglitazone
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: Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 28 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial glucose by 8-point SMBG [ Designated as safety issue: No ]
  • Number of subjects achieving HbA1c below 7% [ Designated as safety issue: No ]
  • Number of hypoglycemic episodes and adverse events [ Designated as safety issue: No ]
  • Weight change [ Designated as safety issue: No ]
  • Insulin dose [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: November 2002
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  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 diabetes
  • Currently treated with OADs alone or combined with other treatment for at least 3 months
  • BMI below 40 kg/m2 and body weight below 125 kg
  • HbA1c greater than or equal to 8%

Exclusion Criteria:

  • Inability to tolerate metformin or contradictions to its use
  • Pregnant, breastfeeding or intention of becoming pregnant
  • Allergy to any of the trial products
  • Inability or unwillingness to perform SMBG
  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: NCT00598793

  Show 26 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Plamen Kozlovski 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: NCT00598793     History of Changes
Other Study ID Numbers: BIASP-2163
Study First Received: January 11, 2008
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Glargine
Insulin
Insulin Aspart
Insulin, Globin Zinc
Metformin
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014