NCT00115973CompletedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 71
- Locations
- 6
- Primary Endpoint
- HbA1c
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
HbA1c
Time Frame: after 3 months
Secondary Outcomes
- Fasting plasma glucose
- Plasma glucose profiles
- Frequency of hypoglycemic events
Investigators
Study Sites (6)
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