Diabetes Mellitus, Type 2Phase 3ELEMENT 2NCT01421459
A Study in Adults With Type 2 Diabetes
A Phase 3 study testing LY2963016, Lantus and OAMs in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 62 sites in 12 countries.
Trial summary
The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications. 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?
- LY2963016, Lantus and OAMs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 759 participants
- Where
- 62 sitesin 12 countries
- Study dates
- Sep 2011to Sep 2012
- 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 Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
- Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
- Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
- Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)
Who cannot join
- Have significant liver, cardiac or gastrointestinal disease
- Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- Have an excessive resistance to insulin or hypersensitivity to Lantus
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have taken any other insulin other than Lantus within the past 30 days
- Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
Trial locations and contacts
62 sites in 12 countries.
62 sites in 12 countries
United States28 sites
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Asheville, North Carolina, 28803
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Atlanta, Georgia, 30329
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Brooksville, Florida, 34601
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Dallas, Texas, 75246
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Des Moines, Iowa, 50314
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Fargo, North Dakota, 58103
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Fort Lauderdale, Florida, 33316
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Houston, Texas, 77074
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Hurst, Texas, 76054
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Longview, Texas, 75605
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Mineola, New York, 11501
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Montgomery, Alabama, 36106
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Nashua, New Hampshire, 03063
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New Hyde Park, New York, 11040
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New Port Richey, Florida, 34652
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Omaha, Nebraska, 68114
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Oviedo, Florida, 32765
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Pembroke Pines, Florida, 33028
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Philadelphia, Pennsylvania, 19107
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Plano, Texas, 75093
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Port Gibson, Mississippi, 39150
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Roswell, Georgia, 30076
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Salisbury, North Carolina, 28144
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San Antonio, Texas, 78229
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Springfield, Missouri, 65807
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Syracuse, New York, 13210
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Tampa, Florida, 33617
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Topeka, Kansas, 66606
Germany7 sites
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Aschaffenburg, 63739
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Dresden, 01219
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Giengen an der Brenz, 89537
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Hamburg, 22607
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Heidelberg, 69115
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Lüneburg, 21339
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Saint Ingbert-Oberwürzbach, 66386
Mexico4 sites
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Guadalajara Jalisco, 04460
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Mexico City, 03300
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Monterrey, 64710
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Tampico, 89000
Poland4 sites
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Bialystok, 15-404
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Gdansk, 80-858
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Ruda Śląska, 41-709
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Wroclaw, 50-403
Puerto Rico4 sites
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Carolina, 00983
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Manati, 00674
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San Juan, 00917-3104
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Santurce, 00909
Spain3 sites
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Málaga, 29006
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Palma de Mallorca, 07014
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Teruel, 44001
Taiwan3 sites
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Taichung, 404
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Taipei, 11031
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Yong Kung City, 71004
Czechia2 sites
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Brandýs nad Labem, 250 01
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Prague, 15500
France2 sites
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Nantes, 44300
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Vieux-Condé, 59690
Hungary2 sites
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Budapest, 1171
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Pápa, 8500
South Korea2 sites
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Seoul, 139-872
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Ulsan, 682-714
Greece1 site
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Thessaloniki, 57010
About this study
Official title: A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study
The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2963016, Lantus, OAMs
- Keywords
- Diabetes, Type 2 Diabetes
- 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.
LY2963016Drug
Administered subcutaneously
LantusDrug
Administered subcutaneously
OAMsDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY2963016 + OAMs | Experimental | LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) [alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)] administered per standard of care for 24 weeks Receives: Drug: LY2963016; Drug: OAMs |
| Lantus + OAMs | Active comparator | Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks Receives: Drug: Lantus; Drug: OAMs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
Measured: Baseline, Endpoint (up to 24 weeks)
Secondary outcomes (12)
Change From Baseline in Insulin Antibody Levels
Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.
Measured: Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
Measured: Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Measured: Baseline and Endpoint [up to 24 weeks (wk)]
Glycemic Variability of Fasting Blood Glucose
Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Measured: Baseline and Endpoint (up to 24 weeks)
Change From Baseline in Body Weight
Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Measured: Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)
Adult Low Blood Sugar Survey (ALBSS)
ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Measured: 4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)
Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Measured: 4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)
Insulin Dose Per Body Weight (U/kg) Per Day
Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Measured: Endpoint (up to 24 weeks)
Insulin Dose (Units)
Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.
Measured: Endpoint (up to 24 weeks)
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)
Incidence of Hypoglycemic Events
A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Measured: Baseline and Endpoint (up to 24 weeks)
Rate Per 30 Days of Hypoglycemic Events
The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.
Measured: Baseline, Endpoint (up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2012
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 (2)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421459
- Sponsor's protocol ID
- 13713
- Other IDs
- I4L-MC-ABEC, 2011-000828-15
- Acronym
- ELEMENT 2
- Status last verified
- Dec 2014
- First submitted
- 19 Aug 2011
- Last updated
- 18 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.
PubMed 29855972Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(R) and Lantus(R) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, >/= 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.
PubMed 29542012
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study
- ClinicalTrials.gov ID
- NCT01421459
- Acronym / sponsor ID
- ELEMENT 2 / 13713
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2963016 + OAMs | Experimental | Drug: LY2963016, Drug: OAMsLY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) [alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)] administered per standard of care for 24 weeks |
| Lantus + OAMs | Active comparator | Drug: Lantus, Drug: OAMsLantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
- Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
- Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
- Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)
Key exclusion criteria (6 listed)
- Have significant liver, cardiac or gastrointestinal disease
- Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- Have an excessive resistance to insulin or hypersensitivity to Lantus
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have taken any other insulin other than Lantus within the past 30 days
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 |
|---|---|---|
| LY2963016Administered subcutaneously | Drug | LY2963016 + OAMs |
| LantusAdministered subcutaneously | Drug | Lantus + OAMs |
| OAMsAdministered orally | Drug | LY2963016 + OAMs, Lantus + OAMs |
Primary outcome
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Endpoint (up to 24 weeks)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
12 secondary outcomes
Change From Baseline in Insulin Antibody Levels
Time frame: Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Time frame: Baseline and Endpoint [up to 24 weeks (wk)]
Glycemic Variability of Fasting Blood Glucose
Time frame: Baseline and Endpoint (up to 24 weeks)
Change From Baseline in Body Weight
Time frame: Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)
Adult Low Blood Sugar Survey (ALBSS)
Time frame: 4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)
Insulin Treatment Satisfaction Questionnaire (ITSQ)
Time frame: 4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)
Insulin Dose Per Body Weight (U/kg) Per Day
Time frame: Endpoint (up to 24 weeks)
Insulin Dose (Units)
Time frame: Endpoint (up to 24 weeks)
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%
Time frame: Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)
Incidence of Hypoglycemic Events
Time frame: Baseline and Endpoint (up to 24 weeks)
Rate Per 30 Days of Hypoglycemic Events
Time frame: Baseline, Endpoint (up to 24 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29855972Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.
- Derived from this study: PubMed 29542012Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(R) and Lantus(R) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, >/= 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.
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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
62 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2963016, Lantus and OAMs in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 62 sites in 12 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 4 inclusion and 6 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Germany, Mexico, Poland, Puerto Rico and 7 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 9 Oct 2014). 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 up to 24 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, Endpoint (up to 24 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 NCT01421459, which also lists 2 linked publications.
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 18 Dec 2014; AzTrials last refreshed its copy on 3 Nov 2026.