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Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03349840
Recruitment Status : Terminated (The study was terminated by the IRB and the Institutional Official after the MOPH and WCMQ audits)
First Posted : November 22, 2017
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Weill Cornell Medical College in Qatar

Brief Summary:
This is a study to be performed in Qatar that will look at the comparison of glycemic control in patients with type 2 diabetes on insulin glargine U100 with insulin degludec over the Ramadan period, to determine whether better glycemic control with fewer hypoglycemic episodes can be achieved.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: Insulin Degludec U100 Drug: Insulin Glargine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label randomised prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan
Actual Study Start Date : January 7, 2018
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Insulin glargine U100
Intervention: half of the subjects will be randomised to insulin glargine U100 basal insulin treatment (or continued on glargine if already treated) that will be administered daily in the evening
Drug: Insulin Glargine
Patients on any basal insulin including insulin glargine will be randomised and either glargine will be continued or will beconverted to basal glargine insulin
Other Name: lantis

Active Comparator: insulin degludec U100
Intervention: half of the subjects will be randomised to insulin degludec U100 basal insulin treatment that will be administered daily in the evening
Drug: Insulin Degludec U100
Patients on any basal insulin including insulin glargine will be randomised and converted to basal degludec insulin
Other Name: tresiba




Primary Outcome Measures :
  1. Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan. [ Time Frame: 6 weeks ]
    To measure HbA1c at the end of Ramadan between arms.


Secondary Outcome Measures :
  1. Comparison of the glucose control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan. [ Time Frame: 6 weeks ]
    To measure fasting glucose at the end of Ramadan between arms.

  2. Hypoglycemia between arms [ Time Frame: 6 weeks ]
    To measure the number hypoglycemia between arms to the end of Ramadan

  3. HbA1c end point achieved [ Time Frame: 6 weeks ]
    To measure the number of subjects who achieve a HbA1c <7.5% at the end of Ramadan between treatment arms

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 14-24 weeks ]
    To measure the number of adverse events between the 2 treatment arms before and after Ramadan



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
  • Female subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English
  • Patients must be on any basal insulin (once daily)
  • Patients must be on any basal insulin (twice daily)
  • Patients on stable dose of oral antidiabetes drugs can be included (No change in the dose for the previous 12 weeks)
  • Body Mass Index <40kg/m2
  • Subjects who have signed informed consent form
  • Patients will be fasting during Ramadan

Exclusion Criteria:

  • Type 1 diabetes
  • Type 2 diabetes on a basal bolus regimen or those on premix insulin or on self-mix insulin
  • On GLP-1 receptor agonists medication
  • On glinide medication
  • Ischaemic heart disease
  • Left bundle branch block on ECG
  • Active diabetic retinopathy or maculopathy requiring acute treatment
  • Unwilling to follow the protocol
  • Pregnancy, intention to become pregnant, breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349840


Locations
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Qatar
Hamad Medical Corporation
Doha, Qatar, 3050
Sponsors and Collaborators
Weill Cornell Medical College in Qatar
Novo Nordisk A/S
Investigators
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Principal Investigator: Stephen Atkin, MD Weill Cornell Medicine Qatar
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Responsible Party: Weill Cornell Medical College in Qatar
ClinicalTrials.gov Identifier: NCT03349840    
Other Study ID Numbers: U1111-1192-2978
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share the individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Weill Cornell Medical College in Qatar:
type 2 diabetes
insulin
glargine u100
degludec
Ramadan
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs