Phase 4
Completed N=117
A Study for Patients With Diabetes Mellitus (IOPA)
Diabetes Mellitus, Type 1 · Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00420095 ↗
Enrolled (actual)
117
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint — 7.91; 7.96 percent of glycosylated hemoglobin — p=0.497
Summary
The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint |
7.91; 7.96 | 0.497 |
| SECONDARY Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment |
0.68; 0.63 | 0.497 |
| SECONDARY Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment |
1.04; 1.18 | 0.419 |
| SECONDARY Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment |
-4.72; -4.56 | 0.741 |
| SECONDARY Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5% |
26; 30; 11; 14 | 0.644 |
| SECONDARY Number of Participants With Laboratory Parameters Significantly Different From Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Hypoglycemia Rate Per Participant Per 30 Days |
0.34; 0.37 | 0.670 |
Eligibility Criteria
Inclusion Criteria
- Clinically diagnosed type 1or type 2 diabetes for at least 2 months
- Aged between 18 and 70 (inclusive)
- Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
- Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1
- Compliance with diet and insulin therapy and performs regular blood glucose monitoring
Exclusion Criteria
- Have used oral antidiabetic agents within 30 days prior to entry into the study
- Receive a total daily dose of insulin >2 units/kilogram
- Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
- Have a body mass index >35 kilograms per square meter (kg/m2)
- Receive chronic systemic glucocorticoid therapy
Data sourced from ClinicalTrials.gov (NCT00420095). 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.