NCT00612040|CompletedPhase 2Results

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN1250-18352007-002474-60

Study Type

interventional

Target

178

Locations

5 countries

Sites

Timeline

RegisteredFeb 2008

StartedJan 2008

CompletionJun 2008

Brief Summary

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

178

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline

Completed

Started Jan 2008

Shorter than P25 for phase_2 diabetes

Geographic Reach

5 countries

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

January 1, 2008

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed

17 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed

7.5 years until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed

Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 25, 2008

Results QC Date

October 16, 2015

Last Update Submit

January 18, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 16 weeks of treatment
Week 0, Week 16

Secondary Outcomes (12)

Change in Fasting Plasma Glucose (FPG)
Week 0, Week 16
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Week 16
Rate of Major and Minor Hypoglycaemic Episodes
Week 0 to Week 16 + 5 days follow up
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Week 0 to Week 16 + 5 days follow up
Rate of Treatment Emergent Adverse Events (AEs)
Week 0 to Week 16 + 5 days follow up
+7 more secondary outcomes

Study Arms (3)

SIBA (D)

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

SIBA (E)

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

IGlar

EXPERIMENTAL

Drug: insulin glargineDrug: insulin aspart

Interventions

insulin degludecDRUG

Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily

SIBA (D)

insulin glargineDRUG

Treat-to-target dose titration scheme, injection s.c., once daily

IGlar

insulin aspartDRUG

Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily

IGlarSIBA (D)SIBA (E)

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes for at least one year
HbA1c 7-11% (both inclusive)
Treated with insulin for at least six months - any regimen

You may not qualify if:

Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation
Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product

Contact the study team to confirm eligibility.