Phase 4
Completed N=515
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
Source: ClinicalTrials.gov NCT00751114 ↗Enrolled (actual)
515
Serious AEs
4.6%
Results posted
Aug 2012
Primary outcomePrimary: HbA1c: Change From Baseline to Study Endpoint — -1.72; -1.13 percent — p=<0.0001
Summary
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.
Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:
* HbA1c level
* Fasting Plasma Glucose (FPG)
* 7-point plasma glucose (PG) profiles
* Percentage of patients with HbA1c <7% and <6.5%
Safety objectives consisted of:
* Hypoglycemia occurrence
* Body weight
* Overall safety
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c: Change From Baseline to Study Endpoint |
-1.72; -1.13 | <0.0001 sig |
| SECONDARY HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint |
67.9; 41.9 | — |
| SECONDARY HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint |
40.2; 16.9 | — |
| SECONDARY Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint |
-60.52; -19.35 | — |
| SECONDARY 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint |
-59.90; -20.39; -66.25; -36.41; -48.00; -19.82 | — |
| SECONDARY Insulin Dose in the Insulin Glargine Group |
0.19; 0.27; 0.38; 0.45; 0.48; 0.50 | — |
| SECONDARY Lipid Profile: Change From Baseline to Study Endpoint |
-7.94; -1.54; -3.68; -0.19; 0.13; 0.57 | — |
| SECONDARY Change in Body Weight From Baseline to Study Endpoint |
0.44; -1.08 | — |
| SECONDARY Number of Patients With at Least One Episode of Symptomatic Hypoglycemia |
108; 35 | — |
| SECONDARY Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia |
3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- With type 2 diabetes diagnosed for at least 6 months,
- Not previously treated with insulin,
- On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months
- HbA1c ≥ 7 and 3 x upper limit of normal range,
- Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatment during the study that are not permitted during the study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry),
- Alcohol or drug abuse within the last year,
- Night shift worker,
- Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
- Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant) within the last 3 months,
- Participation in another clinical trial within the month prior to visit 1,
- History of pancreatitis.
Data sourced from ClinicalTrials.gov (NCT00751114). 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.