A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT01028404|
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : July 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Healthy||Drug: NN1952 Drug: insulin aspart Drug: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
|Experimental: Trial part 1||
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.Drug: insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.Drug: placebo
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
|Experimental: Trial part 2||
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.Drug: insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.Drug: placebo
Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
- Number and severity of adverse events for trial part 1 [ Time Frame: from visit 1 to visit 3 ]
- Number and severity of adverse events for trial part 2 [ Time Frame: from visit 1 to visit 6 ]
- Area under the serum insulin concentration-time curve after a single dose [ Time Frame: after 12 hours ]
- Area under the glucose infusion rate-time curve after a single dose [ Time Frame: after 12 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028404
|Novo Nordisk Investigational Site|
|Neuss, Germany, 41460|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|