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CompletedNCT00400283Updated Feb 24, 2017

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

A Phase 1 interventional study of NNC 55-0414 in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Jan 2001, registered Nov 2006).
Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
40 Years to 74 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 23 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 74 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
23 participants (actual)

Interventions

  • DrugNNC 55-0414
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Berlin, 14050, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00400283
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Nov 16, 2006
Start date
Jan 19, 2001
Primary completion
May 3, 2001
Completion
May 3, 2001
Last update
Feb 24, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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