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

October 17, 2016 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Chula Vista, California, United States, 91911
    - Novo Nordisk Investigational Site
- Florida
  - Miami, Florida, United States, 33142
    - Novo Nordisk Investigational Site
- Kansas
  - Witchita, Kansas, United States, 67214-4942
    - Novo Nordisk Investigational Site
- New Jersey
  - Willingboro, New Jersey, United States, 08046
    - Novo Nordisk Investigational Site
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Novo Nordisk Investigational Site
- Texas
  - San Antonio, Texas, United States, 78229
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c Time Frame: after 3 months	after 3 months

Secondary Outcome Measures

Outcome Measure
Fasting plasma glucose
Plasma glucose profiles
Frequency of hypoglycemic events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

June 26, 2005

First Submitted That Met QC Criteria