Diabetes Mellitus, Type 2Phase 3IMAGINE 6NCT01790438
A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
A Phase 3 study testing LY2605541, Human Insulin NPH and Oral Antihyperglycemic Medications (OAM) in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 63 sites in 11 countries.
Trial summary
The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: Change in participants' overall blood sugar control The rate of night time low blood sugar episodes The number of participants that reach blood sugar… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY2605541, Human Insulin NPH and Oral Antihyperglycemic Medications (OAM)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 641 participants
- Where
- 63 sitesin 11 countries
- Study dates
- Mar 2013to May 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
- Have been receiving 2 or more OAMs for at least 3 months prior to the study
- Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening
- Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Who cannot join
- Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
- Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening
- For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within the 90 days before screening, prescription or over-the-counter medications to promote weight loss
- Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
- Have cardiac disease with functional status that is New York Heart Association Class III or IV
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- Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) [177 millimoles per liter (mmol/L)]
- Have obvious clinical signs or symptoms of liver disease [excluding nonalcoholic fatty liver disease (NAFLD)], acute or chronic hepatitis, nonalcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
- Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening
- Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
- Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
Trial locations and contacts
63 sites in 11 countries.
63 sites in 11 countries
United States20 sites
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Bloomfield Hills, Michigan, 48302
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Chicago, Illinois, 60640
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Concord, California, 94520
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Des Moines, Iowa, 50314
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Eugene, Oregon, 97401
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Fresno, California, 93720
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Greensboro, North Carolina, 27408
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Greer, South Carolina, 29651
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Idaho Falls, Idaho, 83404
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Jacksonville, Florida, 32258
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Knoxville, Tennessee, 37912
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Lancaster, California, 93534
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Levittown, Pennsylvania, 19056
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Los Angeles, California, 90057
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Nashua, New Hampshire, 03063
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Spokane, Washington, 99202
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Spring Valley, California, 91978
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Tempe, Arizona, 85283
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Topeka, Kansas, 66606
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Tustin, California, 92780
Germany6 sites
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Eisenach, 99817
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Hohenmölsen, 06679
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Münster, 48145
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Saarbrücken, 66121
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Saint Ingbert-Oberwürzbach, 66386
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Schkeuditz, 04435
Canada5 sites
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Burnaby, British Columbia, V5G 1T4
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Kelowna, British Columbia, V1Y 1Z9
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Sherbrooke, Quebec, J1G 1B8
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Spruce Grove, Alberta, T7X 2V2
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St. John's, Newfoundland and Labrador, A1E 2C2
Poland5 sites
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Gdynia, 81-557
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Krakow, 30-015
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Lodz, 90-242
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Lublin, 20-538
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Szczecin, 70-506
South Korea5 sites
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Bucheon-si, 420-717
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Daegu, 705-717
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Goyang-si, 410-719
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Seoul, 110-744
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Sungnam-Si, 463-712
Spain5 sites
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Alzira, 46600
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Barcelona, 08022
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Málaga, 29010
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Seville, 41003
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Teruel, 44002
Czechia4 sites
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Brandýs nad Labem, 250 01
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Pardubice, 53002
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Plzen 2-Slovany, 32600
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Prague, 181 00
Hungary4 sites
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Budapest, 1171
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Gyöngyös, 3200
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Nagykanizsa, 8800
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Pápa, 8500
Puerto Rico4 sites
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Las Lomas, 00921
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Manati, 00674
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San Juan, 00917-3104
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Yabucoa, 00767
Argentina3 sites
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Buenos Aires, C1179AAB
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Caba, 2000
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Mar del Plata, B7600FZN
Mexico2 sites
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Guadalajara, 44600
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Monterrey, 64460
About this study
Official title: A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study
The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks:
- Change in participants' overall blood sugar control
- The rate of night time low blood sugar episodes
- The number of participants that reach blood sugar targets without low night time blood sugar episodes
- The total number of low blood sugar episodes reported
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2605541, Human Insulin NPH, Oral Antihyperglycemic Medications (OAM)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2605541Drug
Human Insulin NPHDrug
Oral Antihyperglycemic Medications (OAM)Drug
| Study group | Role | What they receive |
|---|---|---|
| LY2605541 | Experimental | Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Receives: Drug: LY2605541; Drug: Oral Antihyperglycemic Medications (OAM) |
| Human Insulin NPH | Active comparator | Administered by SC injection once daily at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal. Receives: Drug: Human Insulin NPH; Drug: Oral Antihyperglycemic Medications (OAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
Glycosylated hemoglobin A1 (HbA1c) is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Measured: Baseline, 26 Weeks
Secondary outcomes (22)
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline event rate of the corresponding hypoglycemia as covariates, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Measured: Baseline through 26 Weeks
Percentage of Participants With HbA1c ≤6.5% and <7.0%
Percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Measured: 26 Weeks
Fasting Serum Glucose (FSG) (by Laboratory)
LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects.
Measured: 26 Weeks
Fasting Blood Glucose (FBG) (by Self Monitoring)
LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects.
Measured: 26 Weeks
6-Point Self-Monitored Blood Glucose (SMBG)
6-point SMBG profiles were obtained on 3 nonconsecutive days in the week prior to Weeks 0, 4, 8, 12, 16, and 26. The SMBG measurements were performed while fasting (prior to the morning meal [breakfast]), prior to the midday meal (lunch), prior to the evening meal (dinner), at bedtime, at approximately 0300 hours, and the next day fasting (prior to the morning meal). LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), ], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline SMBG at the same time point of the response variable as the fixed effects.
Measured: 26 Weeks
Change From Baseline to 26 Weeks in Body Weight
LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline weight as the fixed effects.
Measured: Baseline, 26 Weeks
HbA1c
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Measured: 26 Weeks
Insulin Dose Per Kilogram (kg) of Body Weight
LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, and treatment-by-visit interaction as the fixed effects.
Measured: 26 Weeks
Time to Steady-State (Stable Maximum Dose)
Steady-state was defined as the first local maximum dose (peak dose value) of LY2605541 or human insulin NPH within the window of -2 to +2 weeks. The median time to steady-state of basal insulin dose estimated from Kaplan-Meier analysis was summarized by treatment.
Measured: Baseline through 26 Weeks
Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index
The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and extreme problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United States (US) population-based algorithm. The EQ-5D-3L US based index scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. LS means were calculated from ANCOVA using treatment, stratification factor (country, baseline sulfonylurea sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]) and baseline value of EQ-5D-3Las covariates.
Measured: Baseline, 26 Weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, higher scores indicate better treatment satisfaction. LS means were calculated using analysis of variance (ANOVA) adjusting for treatment and stratification factors (country, baseline sulfonylureas/meglitinide use [Yes/No], baseline HbA1c [≤8.5% or >8.5%]).
Measured: 26 Weeks
Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
Adult LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (always). Items are categorized in 2 domains: Behavior (or avoidance) with 15 items and Worry (or affect) with 18 items. Sum all the items to obtain a total score (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, stratification factor (country, baseline sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c (≤8.5% or >8.5%), and baseline value of LBSS.
Measured: Baseline, 26 Weeks
Change From Baseline to 26 Weeks in Lipid Profile
Lipid profile includes total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. LS means for post-baseline measures were calculated using MMRM with the fixed effects of stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. LS means for End Of Study measures were calculated using ANCOVA adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL]except for the LDL-C outcome variable), treatment, and baseline value of corresponding lipid outcome variable.
Measured: Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks)
Percentage of Participants With Insulin Antibodies
The percentage of participants with a positive treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR was defined as change from baseline to postbaseline in the anti-LY2605541 antibody level either (1) from undetectable to detectable or (2) from detectable to the value with at least 130% relative increase from baseline. Percentage of participants was calculated by dividing the number of participants with TEAR anytime during the treatment period by the total number of participants analyzed, multiplied by 100.
Measured: Baseline to 26 Weeks
Intra-Participant Variability in FBG by Standard Deviation
Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline FBG variability as the fixed effects.
Measured: 26 Weeks
Intra-Participant Variability in FBG by the Coefficient of Variation
Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG.
Measured: 26 Weeks
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants with at least one hypoglycemia divided by the total number of participants analyzed, multiplied by 100.
Measured: Baseline through 26 Weeks
Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants reaching target HbA1c without nocturnal hypoglycemia divided by the total number of participants analyzed, multiplied by 100.
Measured: 26 Weeks
Percentage of Participants With Injection Site Reactions
The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 Weeks
Rate of Severe Hypoglycemic Events
Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The hypoglycemia rate per 100 years during a defined period was calculated by the number of hypoglycemia events within the period divided by the number of days participant at risk within the period*36525 days.
Measured: Baseline through 26 Weeks
Percentage of Participants With Severe Hypoglycemic Events
Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The percentage of participants with at least one severe hypoglycemia is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26 Weeks
Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores
The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.
Measured: Baseline, 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionMay 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern Time (UTC/GMT -5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790438
- Sponsor's protocol ID
- 12143
- Other IDs
- I2R-MC-BIAK, 2012-003941-13
- Acronym
- IMAGINE 6
- Status last verified
- May 2018
- First submitted
- 11 Feb 2013
- Last updated
- 3 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.
PubMed 36542287
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study
- ClinicalTrials.gov ID
- NCT01790438
- Acronym / sponsor ID
- IMAGINE 6 / 12143
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Posted 3 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks:
- Change in participants' overall blood sugar control
- The rate of night time low blood sugar episodes
- The number of participants that reach blood sugar targets without low night time blood sugar episodes
- The total number of low blood sugar episodes reported
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2605541 | Experimental | Drug: LY2605541, Drug: Oral Antihyperglycemic Medications (OAM)Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. |
| Human Insulin NPH | Active comparator | Drug: Human Insulin NPH, Drug: Oral Antihyperglycemic Medications (OAM)Administered by SC injection once daily at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
- Have been receiving 2 or more OAMs for at least 3 months prior to the study
- Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening
- Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Key exclusion criteria (14 listed)
- Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
- Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening
- For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within the 90 days before screening, prescription or over-the-counter medications to promote weight loss
- Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
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 |
|---|---|---|
| LY2605541 | Drug | LY2605541 |
| Human Insulin NPH | Drug | Human Insulin NPH |
| Oral Antihyperglycemic Medications (OAM) | Drug | Human Insulin NPH, LY2605541 |
Primary outcome
Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 26 Weeks
Glycosylated hemoglobin A1 (HbA1c) is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
22 secondary outcomes
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Time frame: Baseline through 26 Weeks
Percentage of Participants With HbA1c ≤6.5% and <7.0%
Time frame: 26 Weeks
Fasting Serum Glucose (FSG) (by Laboratory)
Time frame: 26 Weeks
Fasting Blood Glucose (FBG) (by Self Monitoring)
Time frame: 26 Weeks
6-Point Self-Monitored Blood Glucose (SMBG)
Time frame: 26 Weeks
Change From Baseline to 26 Weeks in Body Weight
Time frame: Baseline, 26 Weeks
HbA1c
Time frame: 26 Weeks
Insulin Dose Per Kilogram (kg) of Body Weight
Time frame: 26 Weeks
Time to Steady-State (Stable Maximum Dose)
Time frame: Baseline through 26 Weeks
Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index
Time frame: Baseline, 26 Weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
Time frame: 26 Weeks
Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
Time frame: Baseline, 26 Weeks
Change From Baseline to 26 Weeks in Lipid Profile
Time frame: Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks)
Percentage of Participants With Insulin Antibodies
Time frame: Baseline to 26 Weeks
Intra-Participant Variability in FBG by Standard Deviation
Time frame: 26 Weeks
Intra-Participant Variability in FBG by the Coefficient of Variation
Time frame: 26 Weeks
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Time frame: Baseline through 26 Weeks
Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
Time frame: 26 Weeks
Percentage of Participants With Injection Site Reactions
Time frame: Baseline through 26 Weeks
Rate of Severe Hypoglycemic Events
Time frame: Baseline through 26 Weeks
Percentage of Participants With Severe Hypoglycemic Events
Time frame: Baseline through 26 Weeks
Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores
Time frame: Baseline, 26 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36542287Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.
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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 9AM-5PM Eastern Time (UTC/GMT -5 hours, EST) study director
Eli Lilly and Company
63 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2605541, Human Insulin NPH and Oral Antihyperglycemic Medications (OAM) in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 63 sites in 11 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 5 inclusion and 14 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Germany, Canada, Poland, South Korea and 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 May 2018). 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 to 26 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, 26 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 NCT01790438, 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 3 May 2018.