Diabetes MellitusPhase 3NCT03737240
IDegLira HIGH Trial
A Phase 3 study testing IDegLira, Insulin Degludec (U-100) and Insulin Aspart in people with Diabetes Mellitus, run by Emory University at 2 sites in United States.
Trial summary
Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c >9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- IDegLira, Insulin Degludec (U-100) and Insulin Aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2019to 8 Jul 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes, diagnosed for ≥ 6 months
- HBA1c ≥ 9% - 15%
- Previously treated with oral antidiabetic agents, including metformin, sulfonylurea, repaglinide/nateglinide, pioglitazone, dipeptidyl peptidase-4 (DPP4), inhibitors, SGLT2 inhibitors, (monotherapy + basal insulin) or in combination therapy (2-3 agents), and/or on basal insulin (neutral protamine hagedorn (NPH), detemir or glargine U100) at a total daily dose (TDD) 20-50 units (stable doses of metformin and basal insulin for at least 90 days, defined as up to ±10% variability)
- Body mass index (BMI) ≤ 45 Kg/m2
Who cannot join
- Subjects with type 1 diabetes or latent autoimmune diabetes of adults (LADA) (positive glutamic acid decarboxylase (GAD-65) antibody and/or ketones)
- Subjects with a BG > 400 mg/dL during the screening visit and laboratory evidence of diabetic ketoacidosis
- Previous treatment with glucagon-like peptide-1 (GLP-1) agonists (during prior 3 months)
- Previous treatment with basal-bolus insulin (within prior 3 months)
- Recurrent severe hypoglycemia or known hypoglycemia unawareness.
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2
Show all 21Show fewer
- Patients with acute or chronic pancreatitis, pancreatic cancer
- Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease) or significantly impaired renal function (GFR < 30 ml/min).
- Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5 mg/day), parenteral nutrition and immunosuppressive treatment.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Hypersensitivity to study drugs
- Participating in another investigational drug trial
- The receipt of any investigational drug (within 3 months) prior to this trial.
- Previously randomized in this trial
- Heart Failure New York Heart Association (NYHA) class 4 or uncontrolled hypertension (blood pressure > 180/110 mmHg)
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study
- Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
- Known or suspected allergy to trial medications (degludec, liraglutide, aspart), excipients, or related products.
- Subjects could be excluded based on PI's discretion
- Unable to comply with trial protocol, and/or at investigator discretion
- Patients receiving treatment for active diabetic retinopathy or with proliferative retinopathy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Health System
Atlanta, Georgia, 30303
Emory Clinic
Atlanta, Georgia, 30322
About this study
Official title: A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira Versus Basal Bolus in Patients With Poorly Controlled Type 2 Diabetes
Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c >9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations. IDegLira, a fixed-ratio combination (FRC) therapy consisting of insulin degludec and liraglutide, is an attractive option for this population given its proven benefits on glycemic control, weight and compliance. This study aims to show that a simpler regimen using a novel FRC agent (IDegLira) can improve glycemic control, decrease hypoglycemia, reduce the burden of diabetes care, and improve satisfaction/adherence in patients with poorly controlled T2D with HbA1c between ≥ 9-12%. This open-label, treat-to- target, two-arm parallel, controlled trial will randomize participants with T2D and HbA1c ≥ 9%, treated with oral anti-diabetic agents and/or basal insulin therapy to lDegLira or basal-bolus insulin for 26 weeks.
Read the detailed description
Extensive literature has shown that persistent hyperglycemia is associated with short- and long-term complications. Sustained hyperglycemia, also known as glucotoxicity, leads to progressive loss of beta-cell function and is considered a key pathophysiological process in the development of type 2 diabetes (T2D). Patients with severe hyperglycemia may respond poorly to oral anti-diabetic agents (OAD) alone initially and frequently require insulin to achieve glycemic targets. Current guidelines recommend to initiate therapy with basal insulin and progressively step up to basal-bolus insulin in patients with high HbA1c >9%, particularly if symptomatic or with catabolic symptoms.
A basal-bolus insulin regimen increases the risk of hypoglycemia, weight gain and glycemic variability, which are limiting factors in achieving glycemic targets. A basal-bolus insulin regimen is also labor intensive and often requires multiple daily injections, further increasing the burden of diabetes care and decreasing patient adherence. In contrast, simplified treatment plans may improve adherence, leading to glycemic targets achievement. Thus, there is a critical need for simpler regimens that could overcome clinical inertia, improve patient adherence, and decrease glycemic variability in patients with poorly controlled type 2 diabetes. This prospective randomized control trial will compare IDegLira to basal-bolus insulin regimen in achieving glycemic control, while reducing hypoglycemia, glycemic variability, and weight gain in patients with uncontrolled T2D and HbA1c ≥9%.
- Conditions
- Diabetes Mellitus
- Being tested
- IDegLira, Insulin Degludec (U-100), Insulin Aspart
- Keywords
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDegLiraDrug
Also called Xultophy 100/3.6, insulin degludec, liraglutide
Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
Insulin Degludec (U-100)Drug
Also called Tresiba FlexTouch
Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin AspartDrug
Also called NovoLog
Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| IDegLira | Experimental | Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. Receives: Drug: IDegLira |
| Basal-Bolus Insulin | Active comparator | Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. Receives: Drug: Insulin Degludec (U-100); Drug: Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c)
HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Measured: Baseline, Week 26
Secondary outcomes (26)
Average Fasting Blood Glucose
Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL.
Measured: Week1, Week 12, Week 26
Average Daily Blood Glucose
Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management.
Measured: Week1, Week 12, Week 26
Participants With HbA1c <7.0% and no Hypoglycemia
Percent of study participants experiencing HbA1c <7.0% and no hypoglycemia will be compared between groups. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL.
Measured: Week 26
Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia
Percent of study participants reaching A1c < 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL.
Measured: Week 26
Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia
Percent of study participants reaching A1c < 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL.
Measured: Week 26
Participants With HbA1c >10% Achieving HbA1c <7.5%
Percent of study participants with baseline HbA1c >10% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Measured: Baseline, Week 26
Participants With HbA1c >10% Achieving HbA1c <8.0%
Percent of study participants with baseline HbA1c >10% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Measured: Baseline, Week 26
Participants With HbA1c >11% Achieving HbA1c <7.5%
Percent of study participants with baseline HbA1c >11% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Measured: Baseline, Week 26
Participants With HbA1c >11% Achieving HbA1c <8.0%
Percent of study participants with baseline HbA1c >11% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Measured: Baseline, Week 26
Participants With HbA1c <7.0% and no Weight Gain
Percent of study participants reaching A1c < 7% without weight gain will be compared between groups.
Measured: Week 26
Participants With HbA1c <7.0% and no Hypoglycemia
Percent of study participants reaching A1c < 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL.
Measured: Week 12
Number of Participants With Documented Symptomatic Hypoglycemic Events
Documented symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs at any time of the day. Number of participants with documented hypoglycemic events will be compared between study groups.
Measured: Baseline through Week 26
Asymptomatic Hypoglycemic Events
Asymptomatic hypoglycemia is defined as no typical symptoms reported by the study participant but detected by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL. Incidence of asymptomatic hypoglycemic events will be compared between study groups.
Measured: Baseline through Week 26
Number of Participants With Severe Hypoglycemic Events
Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person. Number of participants with severe hypoglycemic events will be compared between study groups.
Measured: Baseline through Week 26
Nocturnal Symptomatic Hypoglycemic Events
Nocturnal symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs between midnight and 5:59 am. Incidence of nocturnal symptomatic hypoglycemic events will be compared between study groups.
Measured: Baseline through Week 26
Nocturnal Asymptomatic Hypoglycemic Events
Nocturnal asymptomatic hypoglycemia is defined as SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL between midnight and 5:59 am. Incidence of nocturnal asymptomatic hypoglycemic events will be compared between study groups.
Measured: Baseline through Week 26
Percentage of Time With Interstitial Glucose <70 mg/dL
Percentage of time with a interstitial glucose level below 70 mg/dL as obtained by CGM will be compared between study groups.
Measured: Baseline through Week 26
Percentage of Time With Interstitial Glucose <54 mg/dL
Percentage of time with a interstitial glucose level below <54 mg/dL as obtained by CGM will be compared between study groups.
Measured: Baseline through Week 26
Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL
Percentage of time with interstitial glucose in the range of 70-180 mg/dL as measured by CGM will be compared between study groups.
Measured: Baseline through Week 26
Glycemic Variability
Glycemic variability will be assessed with continuous glucose monitoring (CGM). It will be calculated using CGM and Standard Deviation.
Measured: Week1, Week 12, Week 26
Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score
Treatment satisfaction will be assessed with the DTSQs. The DTSQs contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained by summing responses to yield a total score between 0 to 48. Higher scores indicate higher satisfaction with diabetes treatment.
Measured: Baseline, Week 12
Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score
Satisfaction with the study treatment will be assessed with items 1, 4, 5, 6, 7, and 8 the DTSQc. Items are rated on a scale of -3 (much less satisfied compared to prior treatment) to 3 (much more satisfied compared to prior treatment). Total scores for these three items range from -18 to +18 with higher scores indicating greater satisfaction with the study treatment compared to their prior treatment.
Measured: Week 26
Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score
Satisfaction with the study treatment will be assessed with the TRIM-D survey. TRIM-D includes 28 items that are scored on a scale from 1 to 5. Total scores are transformed to a scale of 0 to 100 where higher scores indicate increased satisfaction.
Measured: Baseline, Week 12, Week 26
Number of Emergency Room (ER) Visits
The number of emergency room visits occurring during the treatment period will be compared between study groups.
Measured: Baseline through Week 26
Number of Hospital Readmissions
The number of hospital readmissions occurring during the treatment period will be compared between study groups.
Measured: Baseline through Week 26
Total Daily Insulin Dose
The total insulin dose measured in units per day will be compared between study groups.
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start15 Jan 2019
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
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 MellitusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Model description
- Participants will be randomized in a 1 to 1 ratio to receive the study treatment or standard of care.
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Rodolfo Galindo, Emory University
- Investigators
- Rodolfo Galindo, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737240
- Sponsor's protocol ID
- IRB00104726
- Status last verified
- Aug 2023
- First submitted
- 8 Nov 2018
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira Versus Basal Bolus in Patients With Poorly Controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03737240
- Acronym / sponsor ID
- IRB00104726
- Conditions
- Diabetes Mellitus
- Keywords
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c >9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations. IDegLira, a fixed-ratio combination (FRC) therapy consisting of insulin degludec and liraglutide, is an attractive option for this population given its proven benefits on glycemic control, weight and compliance. This study aims to show that a simpler regimen using a novel FRC agent (IDegLira) can improve glycemic control, decrease hypoglycemia, reduce the burden of diabetes care, and improve satisfaction/adherence in patients with poorly controlled T2D with HbA1c between ≥ 9-12%. This open-label, treat-to- target, two-arm parallel, controlled trial will randomize participants with T2D and HbA1c ≥ 9%, treated with oral anti-diabetic agents and/or basal insulin therapy to lDegLira or basal-bolus insulin for 26 weeks.
Detailed description
Extensive literature has shown that persistent hyperglycemia is associated with short- and long-term complications. Sustained hyperglycemia, also known as glucotoxicity, leads to progressive loss of beta-cell function and is considered a key pathophysiological process in the development of type 2 diabetes (T2D). Patients with severe hyperglycemia may respond poorly to oral anti-diabetic agents (OAD) alone initially and frequently require insulin to achieve glycemic targets. Current guidelines recommend to initiate therapy with basal insulin and progressively step up to basal-bolus insulin in patients with high HbA1c >9%, particularly if symptomatic or with catabolic symptoms.
A basal-bolus insulin regimen increases the risk of hypoglycemia, weight gain and glycemic variability, which are limiting factors in achieving glycemic targets. A basal-bolus insulin regimen is also labor intensive and often requires multiple daily injections, further increasing the burden of diabetes care and decreasing patient adherence. In contrast, simplified treatment plans may improve adherence, leading to glycemic targets achievement. Thus, there is a critical need for simpler regimens that could overcome clinical inertia, improve patient adherence, and decrease glycemic variability in patients with poorly controlled type 2 diabetes. This prospective randomized control trial will compare IDegLira to basal-bolus insulin regimen in achieving glycemic control, while reducing hypoglycemia, glycemic variability, and weight gain in patients with uncontrolled T2D and HbA1c ≥9%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1 to 1 ratio to receive the study treatment or standard of care.
| Arm | Type | Receives |
|---|---|---|
| IDegLira | Experimental | Drug: IDegLiraParticipants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. |
| Basal-Bolus Insulin | Active comparator | Drug: Insulin Degludec (U-100), Drug: Insulin AspartParticipants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes, diagnosed for ≥ 6 months
- HBA1c ≥ 9% - 15%
- Previously treated with oral antidiabetic agents, including metformin, sulfonylurea, repaglinide/nateglinide, pioglitazone, dipeptidyl peptidase-4 (DPP4), inhibitors, SGLT2 inhibitors, (monotherapy + basal insulin) or in combination therapy (2-3 agents), and/or on basal insulin (neutral protamine hagedorn (NPH), detemir or glargine U100) at a total daily dose (TDD) 20-50 units (stable doses of metformin and basal insulin for at least 90 days, defined as up to ±10% variability)
- Body mass index (BMI) ≤ 45 Kg/m2
Key exclusion criteria (21 listed)
- Subjects with type 1 diabetes or latent autoimmune diabetes of adults (LADA) (positive glutamic acid decarboxylase (GAD-65) antibody and/or ketones)
- Subjects with a BG > 400 mg/dL during the screening visit and laboratory evidence of diabetic ketoacidosis
- Previous treatment with glucagon-like peptide-1 (GLP-1) agonists (during prior 3 months)
- Previous treatment with basal-bolus insulin (within prior 3 months)
- Recurrent severe hypoglycemia or known hypoglycemia unawareness.
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 |
|---|---|---|
| IDegLiraAlso: Xultophy 100/3.6, insulin degludec, liraglutideParticipants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL). | Drug | IDegLira |
| Insulin Degludec (U-100)Also: Tresiba FlexTouchParticipants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose. | Drug | Basal-Bolus Insulin |
| Insulin AspartAlso: NovoLogParticipants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL. | Drug | Basal-Bolus Insulin |
Primary outcome
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 26
HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
26 secondary outcomes
Average Fasting Blood Glucose
Time frame: Week1, Week 12, Week 26
Average Daily Blood Glucose
Time frame: Week1, Week 12, Week 26
Participants With HbA1c <7.0% and no Hypoglycemia
Time frame: Week 26
Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia
Time frame: Week 26
Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia
Time frame: Week 26
Participants With HbA1c >10% Achieving HbA1c <7.5%
Time frame: Baseline, Week 26
Participants With HbA1c >10% Achieving HbA1c <8.0%
Time frame: Baseline, Week 26
Participants With HbA1c >11% Achieving HbA1c <7.5%
Time frame: Baseline, Week 26
Participants With HbA1c >11% Achieving HbA1c <8.0%
Time frame: Baseline, Week 26
Participants With HbA1c <7.0% and no Weight Gain
Time frame: Week 26
Participants With HbA1c <7.0% and no Hypoglycemia
Time frame: Week 12
Number of Participants With Documented Symptomatic Hypoglycemic Events
Time frame: Baseline through Week 26
Asymptomatic Hypoglycemic Events
Time frame: Baseline through Week 26
Number of Participants With Severe Hypoglycemic Events
Time frame: Baseline through Week 26
Nocturnal Symptomatic Hypoglycemic Events
Time frame: Baseline through Week 26
Nocturnal Asymptomatic Hypoglycemic Events
Time frame: Baseline through Week 26
Percentage of Time With Interstitial Glucose <70 mg/dL
Time frame: Baseline through Week 26
Percentage of Time With Interstitial Glucose <54 mg/dL
Time frame: Baseline through Week 26
Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL
Time frame: Baseline through Week 26
Glycemic Variability
Time frame: Week1, Week 12, Week 26
Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score
Time frame: Baseline, Week 12
Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score
Time frame: Week 26
Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score
Time frame: Baseline, Week 12, Week 26
Number of Emergency Room (ER) Visits
Time frame: Baseline through Week 26
Number of Hospital Readmissions
Time frame: Baseline through Week 26
Total Daily Insulin Dose
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
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.
Rodolfo Galindo, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDegLira, Insulin Degludec (U-100) and Insulin Aspart in people with Diabetes Mellitus, run by Emory University at 2 sites in United States.
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 21 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 8 Sep 2023). 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 in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2023.