Phase 3
Completed N=1,014
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Source: ClinicalTrials.gov NCT02320721 ↗Enrolled (actual)
1,014
Serious AEs
7.4%
Results posted
Jul 2017
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.89; -0.91 percentage of hemoglobin
◆ Published Evidence
Established
56citations · ~7 / year
A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study.
Summary
Primary Objective:
To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c).
Secondary Objectives:
To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:
* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning
* Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event
* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day
* HbA1c change
Linked Publications
-
A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.89; -0.91 | — |
| SECONDARY Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period |
48.3; 47.7 | 0.8415 |
| SECONDARY Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period |
20.2; 22.5 | — |
| SECONDARY Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period |
59.4; 62.7 | — |
| SECONDARY Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period |
60.6; 58.9; 33.3; 35.2 | — |
| SECONDARY Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period |
26.4; 21.5; 14.0; 12.3 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
-1.68; -1.77 | — |
| SECONDARY Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26 |
-1.16; 0.22 | — |
| SECONDARY Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment |
3.7; 2.6 | — |
Eligibility Criteria
Inclusion criteria
- Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
- Signed informed consent.
Exclusion criteria
- HbA1c at screening visit:
- 10.0% for participants taking basal insulin.
- 11.0% for insulin-naïve participants.
- History of type 2 diabetes mellitus for less than 1 year before screening.
- Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
- Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
- Chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
- Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score <24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score <24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
- Participants who had end-stage renal disease (<15 mL/min/1.73m^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02320721) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.