Phase 4
Completed N=402
A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01175811 ↗Enrolled (actual)
402
Serious AEs
5.3%
Results posted
Dec 2013
Primary outcomePrimary: Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint — -1.05; -1.06 percent HbA1c
Summary
The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint |
-1.05; -1.06 | — |
| SECONDARY Change in HbA1c From Baseline to 12 Week Endpoint |
-0.96; -0.96 | — |
| SECONDARY The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks |
6.1; 8.9; 26.4; 27.7; 9.1; 11.9 | 0.344 |
| SECONDARY The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. |
155.0; 157.7; 141.8; 136.5; 137.4; 132.4 | — |
| SECONDARY Daily Dose of Insulin: Total, Basal, and Prandial |
52.9; 54.0; 31.539; 24.717; 21.385; 29.269 | — |
| SECONDARY Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks |
0.26; 0.20; 0.31; 0.29 | — |
| SECONDARY Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial |
0.738; 0.760; 0.440; 0.348; 0.298; 0.412 | — |
| SECONDARY Percentage of Participants With Hypoglycemic Episodes (Incidence) |
54.8; 55.0 | — |
| SECONDARY The Rate of Hypoglycemic Episodes |
0.468; 0.409 | — |
| SECONDARY Percentage of Participants Experiencing a Severe Hypoglycemic Episode |
0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Present with type 2 diabetes mellitus
- Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry
- Have Haemoglobin A1c (HbA1c) >7.0% and 35 kilogram per square meter (kg/m^2).
- Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study.
- Have cardiac disease with a functional status that is Class III or IV
- Have a history of renal or liver disease
- Have used less than or equal to 20 Units per day (U/day) of insulin during the past 90 days for more than 14 days (accumulated).
Data sourced from ClinicalTrials.gov (NCT01175811). 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.