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NCT01028404 Clinical Trial

A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

Healthy Clinical Trial

Official title:
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01028404
Other study ID # NN1952-3646
Secondary ID U1111-1112-28922
Status Completed
Phase Phase 1
First received December 7, 2009
Last updated July 24, 2017
Start date November 2009
Est. completion date June 2010

Study information
Verified date July 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.

The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- FOR TRIAL PART 1, THE FOLLOWING APPLIES:

- Gender: male

- Age: 18-55 years

- BMI (body mass index): 18-28 kg/m2

- Study participants considered to be healthy

- FOR TRIAL PART 2, THE FOLLOWING APPLIES:

- Gender: male or female of no childbearing potential

- Age: 18-65 years

- Type 1 diabetes: BMI (body mass index): 18-28 kg/m2

- Type 2 diabetes: BMI (body mass index): 22-35 kg/m2

- Type 1 or type 2 diabetes for at least 12 months

- Type 1 diabetes: Treatment with insulin for at least 12 months

- Type 2 diabetes: Treatment with insulin for at least 3 months

Exclusion Criteria:

- Known or suspected allergy to the trial product or related products

- Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator

- Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NN1952
Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.
• insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
• placebo
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
• NN1952
Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.
• insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.
• placebo
Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.

Locations
Country Name City State
Germany Novo Nordisk Investigational Site Neuss

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 Number and severity of adverse events for trial part 1 from visit 1 to visit 3
Primary Number and severity of adverse events for trial part 2 from visit 1 to visit 6
Secondary Area under the serum insulin concentration-time curve after a single dose after 12 hours
Secondary Area under the glucose infusion rate-time curve after a single dose after 12 hours
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