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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Multiple Oral Dose, Dose Escalation Trial, Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 55-0414 in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400283
• Other study ID #: NN414-1384
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2006
• Last updated: February 22, 2017
• Start date: January 19, 2001
• Est. completion date: May 3, 2001

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 3, 2001
• Est. primary completion date: May 3, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• NNC 55-0414

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes.

External Links

•   Clinical Trials at Novo Nordisk