Diabetes Mellitus, Type 1Phase 4IOPANCT00420095
A Study for Patients With Diabetes Mellitus (IOPA)
A Phase 4 study testing Human insulin 30/70 and Insulin lispro low mix in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Human insulin 30/70 and Insulin lispro low mix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guangzhou, 510120
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hangzhou, 310003
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Harbin, 150086
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hefei, 230022
About this study
Official title: Comparison of HbA1c in Type 1 or Type 2 Diabetic Patients Using Insulin Treated Twice Daily With Either Insulin Lispro Low Mixture or Human Insulin Mix 30/70
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.
- Being tested
- Human insulin 30/70, Insulin lispro low mix
- Keywords
- diabetes, type 1, type 2
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human insulin 30/70Drug
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Insulin lispro low mixDrug
Also called LM, Low Mix, Humalog
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Human insulin mix 30/70 Receives: Drug: Human insulin 30/70 |
| 2 | Experimental | Insulin lispro low mix Receives: Drug: Insulin lispro low mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.
Measured: Baseline and 12 weeks of each treatment
Secondary outcomes (6)
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment
Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.
Measured: Baseline and at 12 weeks of each treatment
Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment
Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint
Measured: Baseline and 12 weeks of each treatment
Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment
Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint
Measured: Baseline and 12 weeks of each treatment
Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.
Measured: 12 weeks of each treatment
Number of Participants With Laboratory Parameters Significantly Different From Baseline
Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.
Measured: Baseline and 12 weeks of each treatment
Hypoglycemia Rate Per Participant Per 30 Days
Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.
Measured: over 12 weeks of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420095
- Sponsor's protocol ID
- 11423
- Other IDs
- F3Z-GH-IOPA
- Acronym
- IOPA
- Status last verified
- Jun 2009
- First submitted
- 5 Jan 2007
- Last updated
- 17 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No