NCT01569841

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3 diabetes

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 17, 2015

Completed
Last Updated

February 18, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

March 30, 2012

Results QC Date

October 16, 2015

Last Update Submit

January 21, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)

    Time within the glycaemic target range \[\> 70 mg/dL (3.9 mmol/L) and \< 130 mg/dL (7.2 mmol/L)\] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.

    CGM occured during the last 2 weeks of the 6 weeks treatment period.

Secondary Outcomes (5)

  • Mean Interstitial Glucose (IG) Based on 14 Days of CGM

    CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.

  • Fasting Plasma Glucose (FPG)

    At the end of each 6 week treatment period.

  • Glycosylated Haemoglobin (HbA1c)

    At the end of each 6 week treatment period.

  • Number of Treatment Emergent Adverse Events (AEs)

    Within each week 6 treatment period

  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

    Hypoglycemic episodes reported within each 6 week treatment period.

Study Arms (2)

IDeg

EXPERIMENTAL
Drug: insulin degludec

IGlar

ACTIVE COMPARATOR
Drug: insulin glargine

Interventions

insulin degludecDRUG

Administered subcutaneously (s.c., under the skin) once daily.

IDeg
insulin glargineDRUG

Administered subcutaneously (s.c., under the skin) once daily.

IGlar

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • HbA1c (glycosylated haemoglobin) below or equal to 8.5%
  • Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
  • BMI (body mass index) below 35 kg/m\^2

You may not qualify if:

  • Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
  • Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
  • Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
  • Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Clinical Trial Call Center

Minneapolis, Minnesota, 55416-2699, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

insulin degludecInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Public Access to Clinical Trials
Organization
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 18, 2016

Results First Posted

November 17, 2015

Record last verified: 2016-01

Locations

US(1)