Phase 3
Completed N=878
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
Source: ClinicalTrials.gov NCT01676220 ↗Enrolled (actual)
878
Serious AEs
8.5%
Results posted
Apr 2015
Primary outcomePrimary: Change in HbA1c From Baseline to Month 6 Endpoint — -1.42; -1.46 percentage of hemoglobin
Summary
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of:
- occurrence of nocturnal hypoglycemia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Month 6 Endpoint |
-1.42; -1.46 | — |
| SECONDARY Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 |
15.5; 17.4 | 0.4536 |
| SECONDARY Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint |
-2.16; -2.33 | — |
| SECONDARY Variability of Preinjection SMPG at Month 6 Endpoint |
18.70; 18.33 | — |
| SECONDARY Percentage of Participants With HbA1c <7% at Month 6 |
43.1; 42.1 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint |
-3.41; -3.80 | — |
| SECONDARY Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6 |
26.2; 29.5 | — |
| SECONDARY Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 |
-2.63; -3.01; -3.28; -3.72; -3.69; -4.08 | — |
| SECONDARY Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint |
-2.72; -2.90 | — |
| SECONDARY Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint |
1.53; 1.41 | — |
| SECONDARY Change in Daily Basal Insulin Dose From Baseline to Month 6 |
0.43; 0.34 | — |
| SECONDARY Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint |
4.89; 5.12 | — |
| SECONDARY Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 |
58.9; 63.2; 1.4; 2.1; 39.1; 44.1 | — |
Eligibility Criteria
Inclusion criteria
- Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
- Signed written informed consent.
Exclusion criteria
- HbA1c less than ( ) 11% (> 97 mmol/mol)
- History of type 2 diabetes mellitus for less than 1 year before screening
- Less than 6 months before screening with non-insulin antihyperglycemic treatment
- Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening
- Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit
- Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)
- Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01676220). 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.