A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-19

Study Completion Date

2001-05-03

Brief Summary

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This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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NNC 55-0414

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Diet treatment only for at least two weeks
* Body mass index (BMI) between 22-34 kg/m2 inclusive
* HbA1C between 6.5-12.0% inclusive
* Fasting blood glucose (FBG) between 7.0-18.0 mmol/L inclusive
* Patients should be negative (lesser than 70 kU/l) for antibodies against glutamic acid decarboxylase (GAD)

Exclusion Criteria

* Pharmacological treatment with medication or pancreatitis that the Investigator expected to interfere with blood glucose levels
* History of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the Investigator
* Impaired renal function, serum creatinine greater than 150µmol/L
* Patients, who were known to have serum hepatitis or who were carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or had a positive result to the test for HIV 1/2 antibodies
* Patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing
* Patients, who had donated plasma or blood in the past month, or in excess of 500 mL in the past 12 weeks
* Patients who had a significant history of alcoholism or drug/chemical abuse

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No