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Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00592969
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: metformin Drug: biphasic insulin aspart Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes
Actual Study Start Date : December 3, 2003
Primary Completion Date : November 2, 2004
Study Completion Date : November 2, 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. PPBG values
  2. Glucose profiles
  3. Hypoglycemia
  4. Adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with insulin NPH or are insulin-naive
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-11.0%

Exclusion Criteria:

  • Participation in any other clinical trial involving investigational products within the last 3 months
  • History of drug or alcohol dependence
  • Known impaired hepatic function
  • Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592969


Locations
Argentina
Novo Nordisk Investigational Site
Mariano Acosta s/n, Argentina, 5016
Brazil
Novo Nordisk Investigational Site
Santa Efigenia, Brazil, 30150-320
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00592969     History of Changes
Other Study ID Numbers: BIASP-1570
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Metformin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs