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Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00660374
First received: February 28, 2008
Last updated: June 15, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin NPH
Drug: EX1000
 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: Assessment of Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fructosamine [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • FPG [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • 4-point SMPG 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 (including injection site reactions) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Laboratory safety parameters (haematology, biochemistry and lipids) [ 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: Yes ]
  • HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: insulin NPH
"Soft-treat-to-target" dose titration scheme, injection s.c.
Other Name: Insulatard® 100 IU/mL
Experimental: B Drug: EX1000
"Soft-treat-to-target" dose titration scheme, injection s.c.

  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
  • Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
  • Body Mass Index (BMI) less than or equal to 40 kg/m2
  • HbA1c less than or equal to 9.5%
  • FPG less than or equal to 12 mmol/L

Exclusion Criteria:

  • Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
  • Treatment with more than 1 IU/kg NPH insulin daily
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial products or related products
  • Receipt of any investigational drug within one month prior to this trial
  • Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660374

Locations
Brazil
Salvador, Brazil, 40420-000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Annette Stender, M.Sc. Pharm Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00660374     History of Changes
Other Study ID Numbers: EX1000-1865
Study First Received: February 28, 2008
Last Updated: June 15, 2012
Health Authority: Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on May 16, 2013