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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00400283
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: NNC 55-0414	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 19, 2001
• Actual Primary Completion Date: May 3, 2001
• Actual Study Completion Date: May 3, 2001

Outcome Measures

Primary Outcome Measures

1. To determine the safety and the tolerability of ascending multiple oral doses of NNC 55 0414 in patients with type 2 diabetes. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Berlin		Germany	14050

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00400283
• Other Study ID Numbers: NN414-1384
• First Posted: Nov 16, 2006
• Last Update Posted: Feb 24, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 24, 2017