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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00115973
First received: June 26, 2005
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Delivery Systems
Device: pump
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Frequency of hypoglycemic events [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: June 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00115973

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
United States, Florida
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33142
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Witchita, Kansas, United States, 67214-4942
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Willingboro, New Jersey, United States, 08046
United States, North Dakota
Novo Nordisk Clinical Trial Call Center
Fargo, North Dakota, United States, 58104
United States, Texas
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: William Lyness, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00115973     History of Changes
Other Study ID Numbers: PDS253-1665
Study First Received: June 26, 2005
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novo Nordisk A/S:
Pump
Diabetes

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

ClinicalTrials.gov processed this record on August 28, 2014