Phase 4
Completed N=814
A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03018938 ↗Enrolled (actual)
814
Serious AEs
10.8%
Results posted
Mar 2020
Primary outcomePrimary: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) — -2.158; -2.000 Percentage of HbA1c — p=0.1009
◆ Published Evidence
Emerging
1citation · ~0 / year
A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience.
Summary
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
Linked Publications
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A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) |
-2.158; -2.000 | 0.1009 |
| SECONDARY Change From Baseline to Week 48 in HbA1c |
-2.029; -1.829 | 0.0246 sig |
| SECONDARY Percentage of Participants Who Achieve HbA1c <7% at Week 24 |
33.9; 28.3 | 0.0941 |
| SECONDARY Percentage of Participants Who Achieve HbA1c <7% at Week 48 |
23.3; 23.4 | 0.8592 |
| SECONDARY Change From Baseline to Week 24 in Venous Fasting Plasma Glucose |
-2.332; -2.755 | 0.0497 sig |
| SECONDARY Change From Baseline to Week 48 in Venous Fasting Plasma Glucose |
-2.527; -3.174 | 0.0010 sig |
| SECONDARY Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose |
-2.105; -2.374; -4.184; -4.101 | 0.2193 |
| SECONDARY Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose |
-2.233; -2.724; -4.372; -4.359 | 0.0160 sig |
| SECONDARY Total Daily Insulin Dose at Week 24 and 48 |
24.89; 14.58; 24.22; 15.35 | — |
| SECONDARY Change From Baseline to Week 24 in Body Weight |
1.226; 0.559 | 0.0166 sig |
| SECONDARY Change From Baseline to Week 48 in Body Weight |
1.393; 0.639 | 0.0086 sig |
| SECONDARY Rate of Hypoglycemia at Week 24 and 48 |
0.54; 0.24; 0.33; 0.20; 1.60; 0.63 | — |
| SECONDARY Number of Participants With Insulin Treatment Change at Week 48 |
23; 31; 23; 24; 15; 9 | — |
| SECONDARY Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24 |
33.1; 29.0 | 0.2009 |
| SECONDARY Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48 |
23.9; 23.7 | 0.8054 |
| SECONDARY Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score |
-0.9; -0.8 | 0.7553 |
Eligibility Criteria
Inclusion Criteria
- have type 2 diabetes as defined by World Health Organization (WHO) criteria
- are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
- most recent HbA1c value ≥7.5% within 12 weeks of study entry
- in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
- willing to start with insulin treatment
Exclusion Criteria
- have a diagnosis of type 1 diabetes
- have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
- have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
- are pregnant or breastfeeding, or intend to become pregnant during the course of the study
- are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
Data sourced from ClinicalTrials.gov (NCT03018938) 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.