Gla-300 arm for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Type 2 Diabetes Mellitus+4 More
Insulin glargine 300 U/mL - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to compare the efficacy and safety of two diabetes treatments, Gla-300 and IDeg-100, in insulin-naïve patients with Type 2 Diabetes Mellitus and renal impairment. The hypothesis is that Gla-300 is non-inferior to IDeg-100 in terms of glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in terms of reducing Hemoglobin A1c levels, without an increased potential risk of hypoglycemia.

Eligible Conditions
  • Type 2 Diabetes Mellitus
  • deteriorating renal function

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline to end of study (25 weeks)

At week 24
Percentage of participants reaching HbA1c target of <7.0% at Week 24
Baseline to 24 weeks
Change in 7-point SMPG profiles from baseline to Week 24, per time point within 24-hour period
Change in Fasting Plasma Glucose (FPG) from baseline to Week 24
Change in fasting Self-Measured Plasma Glucose (SMPG) from baseline to Week 24
Gamma-linolenic acid
Week 25
Number of participants with adverse events (AEs)) and serious adverse events (SAEs), including adverse events of special interest (AESIs)
Hypoglycemia
Hypoglycemia
Rate of hypoglycemia per participant-year computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window).
Hypoglycemia

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

IDeg-100 arm
1 of 2
Gla-300 arm
1 of 2

Active Control

Experimental Treatment

630 Total Participants · 2 Treatment Groups

Primary Treatment: Gla-300 arm · No Placebo Group · Phase 4

Gla-300 arm
Drug
Experimental Group · 1 Intervention: Insulin glargine 300 U/mL · Intervention Types: Drug
IDeg-100 arm
Drug
ActiveComparator Group · 1 Intervention: Insulin degludec 100 U/mL · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to end of study (25 weeks)

Who is running the clinical trial?

SanofiLead Sponsor
2,032 Previous Clinical Trials
2,955,874 Total Patients Enrolled
127 Trials studying Type 2 Diabetes Mellitus
108,312 Patients Enrolled for Type 2 Diabetes Mellitus

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had adequate blood pressure control with stable antihypertensive therapy at trial inclusion.
You are capable of understanding the written informed consent, and provide written informed consent.
You are willing and able to complete the eDiary and agree to comply with protocol requirements.
You are willing and able to fast without having administered study drug for scheduled site visits.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.