NCT03349840

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

November 2, 2017

Last Update Submit

June 4, 2020

Conditions

Type2 Diabetes

Keywords

type 2 diabetesinsulinglargine u100degludecRamadan

Outcome Measures

Primary Outcomes (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.

    To measure HbA1c at the end of Ramadan between arms.

    6 weeks

Secondary Outcomes (4)

  • Comparison of the glucose control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan.

    6 weeks

  • Hypoglycemia between arms

    6 weeks

  • HbA1c end point achieved

    6 weeks

  • Incidence of Treatment-Emergent Adverse Events

    14-24 weeks

Study Arms (2)

Insulin glargine U100

ACTIVE COMPARATOR

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

insulin degludec U100

ACTIVE COMPARATOR

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

Interventions

Insulin Degludec U100DRUG

Patients on any basal insulin including insulin glargine will be randomised and converted to basal degludec insulin

Also known as: tresiba
insulin degludec U100
Insulin GlargineDRUG

Patients on any basal insulin including insulin glargine will be randomised and either glargine will be continued or will beconverted to basal glargine insulin

Also known as: lantis
Insulin glargine U100

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

insulin degludecInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Stephen Atkin, MD

    Weill Cornell Medicine Qatar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label randomised prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 22, 2017

Study Start

January 7, 2018

Primary Completion

August 3, 2018

Study Completion

December 31, 2018

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

There is no plan to share the individual participant data

Locations

QA(1)