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

Novo Nordisk A/S71 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2 Delivery Systems

Interventions

pumpDEVICE

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (6)

Novo Nordisk Investigational Site

Chula Vista, California, United States

Novo Nordisk Investigational Site

Miami, Florida, United States

Novo Nordisk Investigational Site

Witchita, Kansas, United States

Novo Nordisk Investigational Site

Willingboro, New Jersey, United States

Outcomes

Primary Outcomes

HbA1c

Time frame: after 3 months

Secondary Outcomes

Fasting plasma glucose

Plasma glucose profiles

Frequency of hypoglycemic events

Data from ClinicalTrials.gov

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