Diabetes Mellitus, Type 2Phase 4IOOXNCT00377858

Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)

A Phase 4 study testing Insulin lispro mid mixture (MM) and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 25 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents. Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin lispro mid mixture (MM) and Insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 484 participants
Where: 25 sitesin 7 countries
Study dates: Aug 2006to Sep 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have type 2 diabetes
Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Who cannot join

Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
Have a body mass index greater than 40 kg/m2.
Have had more than one episode of severe hypoglycemia in the last24 weeks
Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease

Trial locations and contacts

25 sites in 7 countries.

Country

City, postcode or hospital

25 sites in 7 countries

France5 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.
Mantes-la-Jolie, 78200
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Menton, 06500
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Pau, 64000
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Poitiers, 86000
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Toulouse, 31082

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Spain5 sites

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Alicante, 03114
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Almería, 04001
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Barcelona, 08017
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Bilbao, 48013
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Málaga, 29010

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Canada4 sites

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Granby, Quebec, J2G 1T7
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London, Ontario, N6A 4L2
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Regina, Saskatchewan, S4P 0W5
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Sherbrooke, Quebec, J1G 5K2

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Australia3 sites

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Fitzroy, Victoria, 3065
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Fremantle, Western Australia, 6160
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Keswick, South Australia, 5035

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Russia3 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.
Arkhangelsk, 163045
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Moscow, 117036
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Saint Petersburg, 193257

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South Korea3 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.
Goyang-Si/Kyunggi-Do, 410-719
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.
Kwangju, 501-757
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Seoul, 110-746

Other trials in South Korea

Mexico2 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.
Chihuahua City, 31238
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Guadalajara, 44620

Other trials in Mexico

About this study

Official title: Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin lispro mid mixture (MM), Insulin glargine
Keywords: diabetes, type 2
Medical subject headings: 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.

Insulin lispro mid mixture (MM)Drug
Also called Humalog, Mid Mix
Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
Insulin glargineDrug
Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

Study groups in NCT00377858
Study group	Role	What they receive
Insulin Lispro Mid Mixture	Experimental	Insulin lispro mid mixture (MM) up to three times a day (TID) Receives: Drug: Insulin lispro mid mixture (MM)
Insulin Glargine	Active comparator	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed. Receives: Drug: Insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Level of hemoglobin A1c at endpoint.
Measured: 36 weeks

Secondary outcomes (11)

Hemoglobin A1c (HbA1c) at Interval Visits
Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.
Measured: 12, 24, and 36 weeks
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Measured: 12-24-36 weeks
7-point Self-monitored Blood Glucose Profiles
Actual daily mean blood glucose levels at specified time points.
Measured: Baseline, 12-24-36 weeks
Glycemic Variability
Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
Measured: Baseline, 12-24-36 weeks
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Measured: Baseline to 36 Weeks
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Measured: Baseline to 36 Weeks
Number of Patients With at Least One Severe Hypoglycemia Episode
Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Measured: Baseline to 36 Weeks
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Measured: 36 Weeks
Endpoint Insulin Dose; Total, Basal, and Prandial
Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Measured: 36 Weeks
Number of Insulin Injections Per Day
Measured: Weeks 12, 24, 30, 36
Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
Measured: Baseline, 36 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Sep 2008

First posted19 Sep 2006 (estimated)
Study startAug 2006
Primary completionSep 2008
Study completionSep 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies 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: Parallel groups
Masking: None (open label)
Enrolment: 484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00377858
Sponsor's protocol ID: 10936
Other IDs: F3Z-MC-IOOX
Acronym: IOOX
Status last verified: Dec 2009
First submitted: 11 Sep 2006
Last updated: 9 Dec 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.
PubMed 23489710

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections
ClinicalTrials.gov ID: NCT00377858
Acronym / sponsor ID: IOOX / 10936
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes, type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 484 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 19 Sep 2006 (estimated)
Results: Posted 3 Dec 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin Lispro Mid Mixture	Experimental	Drug: Insulin lispro mid mixture (MM)Insulin lispro mid mixture (MM) up to three times a day (TID)
Insulin Glargine	Active comparator	Drug: Insulin glargineInsulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have type 2 diabetes
Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Key exclusion criteria (7 listed)

Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
Have a body mass index greater than 40 kg/m2.
Have had more than one episode of severe hypoglycemia in the last24 weeks

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin lispro mid mixture (MM)Also: Humalog, Mid MixPatient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks	Drug	Insulin Lispro Mid Mixture
Insulin glarginePatient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks	Drug	Insulin Glargine

Primary outcome

Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Time frame: 36 weeks
Level of hemoglobin A1c at endpoint.

11 secondary outcomes

Hemoglobin A1c (HbA1c) at Interval Visits
Time frame: 12, 24, and 36 weeks
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Time frame: 12-24-36 weeks
7-point Self-monitored Blood Glucose Profiles
Time frame: Baseline, 12-24-36 weeks
Glycemic Variability
Time frame: Baseline, 12-24-36 weeks
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Time frame: Baseline to 36 Weeks
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Time frame: Baseline to 36 Weeks
Number of Patients With at Least One Severe Hypoglycemia Episode
Time frame: Baseline to 36 Weeks
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Time frame: 36 Weeks
Endpoint Insulin Dose; Total, Basal, and Prandial
Time frame: 36 Weeks
Number of Insulin Injections Per Day
Time frame: Weeks 12, 24, 30, 36
Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Time frame: Baseline, 36 Weeks

Results and safety

Results posted to the registry on 3 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Lispro Mid Mixture	242	211
Insulin Glargine	242	215

Primary outcome: Hemoglobin A1c (HbA1c) at 36 Week Endpoint

Time frame: 36 weeks. Least squares mean (Standard Error). Unit: percent HbA1c

Measure	Insulin Lispro Mid Mixture n = 188	Insulin Glargine n = 195
Value	7.66 (0.37)	7.49 (0.36)

Insulin Lispro Mid Mixture vs Insulin Glargine: Mean Difference (Net): 0.17 (95% CI -0.03 to 0.37), p = 0.097, ANCOVA

Population analysed: Number of participants in the per-protocol population. Last observation carried forward.

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Lispro Mid Mixture	11 of 239 (4.6%)	91 of 239 (38.1%)	Not reported
Insulin Glargine	11 of 240 (4.6%)	92 of 240 (38.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23489710Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

25 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin lispro mid mixture (MM) and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 25 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France, Spain, Canada, Australia, Russia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c (HbA1c) at 36 Week Endpoint (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2009.