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OpenTrials
Completed

NCT Number: NCT00115973

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

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.

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Key information

Conditions

Diabetes Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pump

Device

insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 3 months

Secondary outcomes

  1. Fasting plasma glucose

  2. Plasma glucose profiles

  3. Frequency of hypoglycemic events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 27, 2005
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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