A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115973
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the final clinic visit. A subject's participation in this trial would be expected to be up to 16 weeks.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Delivery Systems Device: pump Drug: insulin aspart Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Stepwise Basal Insulin Dose Titration Study Using Continuous Subcutaneous Insulin Infusion (CSII) in Oral Antidiabetic Drug-Treated Type 2 Diabetes Mellitus Subjects Followed by a 10-Week Out-Patient Maintenance Phase
Study Start Date : June 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 3 months ]

Secondary Outcome Measures :
  1. Fasting plasma glucose
  2. Plasma glucose profiles
  3. Frequency of hypoglycemic events

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes diagnosis at least 2 years ago
  • Body Mass Index (BMI): 26-40 kg/m^2 (both inclusive)
  • HbA1c: 7.5-10% (both inclusive)
  • FPG values at least 140 mg/dl (7.8 mmol/l)

Exclusion Criteria:

  • Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization (steroids or non-specific beta-blockers)
  • Current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use
  • Known or suspected allergy to trial products or related products

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 identifier (NCT number): NCT00115973

United States, California
Novo Nordisk Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Novo Nordisk Investigational Site
Miami, Florida, United States, 33142
United States, Kansas
Novo Nordisk Investigational Site
Witchita, Kansas, United States, 67214-4942
United States, New Jersey
Novo Nordisk Investigational Site
Willingboro, New Jersey, United States, 08046
United States, North Dakota
Novo Nordisk Investigational Site
Fargo, North Dakota, United States, 58104
United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00115973     History of Changes
Other Study ID Numbers: PDS253-1665
First Posted: June 27, 2005    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Novo Nordisk A/S:

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