Diabetes Mellitus, Type 1Phase 4NCT00985712

A Study on the Effect of 2 Pen Devices on HbA1c

A Phase 4 study testing Insulin Lispro, Huminsulin Regular and HumaPen Memoir in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 29 sites in Germany.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function. Read more about this study

Who is it for?: Ages 8 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Insulin Lispro, Huminsulin Regular and HumaPen Memoir
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 263 participants
Where: 29 sitesGermany
Study dates: Oct 2009to Jul 2011
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 8 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Type 1 diabetes mellitus
receiving at least 3 prandial injections per day with short-acting or analogue insulin

Who cannot join

Insulin pump therapy
receiving pre-mixed insulin preparations

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Germany29 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.
Aschaffenburg, 63739
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Aßlar, 35614
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Bad Mergentheim, 97980
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Berlin, 14089
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Bosenheim, 55545
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Diez, 65582
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Dresden, 01307
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Erlangen, 91054
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Essen, 45355
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Falkensee, 14612
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Flensburg, D-24939
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Frankfurt, 60388
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Fulda, 36037
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Giessen, 35385
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Hamburg, 21073
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Hanover, 30173
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Herdecke, 58313
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Leipzig, 04103
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Mainz, 55116
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Münster, 48153
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Neuwied, 56564
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Rehlingen-Siersburg, 66780
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Rotenburg-Fulda, 36199
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Saarbrücken, 66121
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Schkeuditz, 04435
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Schwedt, 16303
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Tübingen, 72076
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Warburg, 34414
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Wuppertal, 42283

Other trials in Germany

About this study

Official title: A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults With Type 1 Diabetes: Novel Pen With Memory Function (HumaPen Memoir) vs. Conventional Pen Without Memory Function (HumaPen Luxura)

Conditions: Diabetes Mellitus, Type 1
Being tested: Insulin Lispro, Huminsulin Regular, HumaPen Memoir, HumaPen Luxura
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin LisproDrug
Also called Humalog, LY275585
subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
Huminsulin RegularDrug
Also called Huminsulin Normal, LY041001
subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
HumaPen MemoirDevice
subcutaneously, daily for 24 weeks
HumaPen LuxuraDevice
subcutaneously, daily for 24 weeks

Study groups in NCT00985712
Study group	Role	What they receive
HumaPen Luxura	Experimental	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks Receives: Drug: Insulin Lispro; Drug: Huminsulin Regular; Device: HumaPen Luxura
HumaPen Memoir	Experimental	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks Receives: Drug: Insulin Lispro; Drug: Huminsulin Regular; Device: HumaPen Memoir

What is being measured

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

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.
Measured: Baseline, Week 24

Secondary outcomes (4)

Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint
Measured: Week 24
Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint
IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.
Measured: Week 24
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24
Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.
Measured: Baseline through Week 24
30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24
Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.
Measured: Baseline through Week 24

Timeline

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

Oct 2009Jul 2011

First posted28 Sep 2009 (estimated)
Study startOct 2009
Primary completionJul 2011
Study completionJul 2011

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: Parallel groups
Masking: None (open label)
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985712
Sponsor's protocol ID: 12704
Other IDs: H9D-SB-ITAE
Status last verified: May 2012
First submitted: 23 Sep 2009
Last updated: 4 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults With Type 1 Diabetes: Novel Pen With Memory Function (HumaPen Memoir) vs. Conventional Pen Without Memory Function (HumaPen Luxura)
ClinicalTrials.gov ID: NCT00985712
Acronym / sponsor ID: 12704
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 28 Sep 2009 (estimated)
Results: Posted 4 Jun 2012

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
HumaPen Luxura	Experimental	Drug: Insulin Lispro, Drug: Huminsulin Regular, Device: HumaPen LuxuraParticipant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
HumaPen Memoir	Experimental	Drug: Insulin Lispro, Drug: Huminsulin Regular, Device: HumaPen MemoirParticipant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Who may qualify

Ages: 8 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Type 1 diabetes mellitus
receiving at least 3 prandial injections per day with short-acting or analogue insulin

Key exclusion criteria (2 listed)

Insulin pump therapy
receiving pre-mixed insulin preparations

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 LisproAlso: Humalog, LY275585subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks	Drug	HumaPen Luxura, HumaPen Memoir
Huminsulin RegularAlso: Huminsulin Normal, LY041001subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks	Drug	HumaPen Luxura, HumaPen Memoir
HumaPen Memoirsubcutaneously, daily for 24 weeks	Device	HumaPen Memoir
HumaPen Luxurasubcutaneously, daily for 24 weeks	Device	HumaPen Luxura

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint
Time frame: Baseline, Week 24
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.

4 secondary outcomes

Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint
Time frame: Week 24
Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint
Time frame: Week 24
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24
Time frame: Baseline through Week 24
30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24
Time frame: Baseline through Week 24

Results and safety

Results posted to the registry on 4 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HumaPen Luxura	133	127
HumaPen Memoir	130	123

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint

Time frame: Baseline, Week 24. Least squares mean (95% Confidence Interval). Unit: percentage of glycosylated hemoglobin

Measure	HumaPen Luxura n = 128	HumaPen Memoir n = 129
Value	-0.48 (-0.64 to -0.32)	-0.43 (-0.59 to -0.28)

HumaPen Luxura vs HumaPen Memoir: LS Mean Difference (Final Values): 0.05 (95% CI -0.17 to 0.26), p = 0.6692, Mixed Models Analysis

Population analysed: Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HumaPen Luxura	7 of 131 (5.3%)	52 of 131 (39.7%)	Not reported
HumaPen Memoir	8 of 130 (6.2%)	50 of 130 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Lispro, Huminsulin Regular and HumaPen Memoir in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 29 sites in Germany.

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 2 inclusion and 2 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany. 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 4 Jun 2012). 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?

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint (time frame: Baseline, Week 24). 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 NCT00985712.

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 4 Jun 2012.