A Phase 3 interventional study of insulin degludec/liraglutide and insulin glargine in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 91 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 557 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
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Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.
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Inclusion Criteria: - Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m\^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal range (UNR) - Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - History of chronic pancreatitis or idiopathic acute pancreatitis
Drug: insulin degludec/liraglutide
Drug: insulin glargine
Drug pages: Insulin degludec · Liraglutide
Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of treatment
Time frame: Week 0, week 26
Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks of treatment
Time frame: Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
Time frame: During 26 weeks of treatment
The trial was conducted at 75 sites in 10 countries as follows: Argentina: 5 sites; Australia: 4 sites; Greece: 6 sites, Hungary: 4 sites; Mexico: 5 sites, Russian Federation: 11 sites; Slovakia: 11 sites, South Africa: 4 sites; Spain: 6 sites, United States: 19 sites.
| Milestone | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) |
|---|---|---|
| Started | 278 | 279 |
| Completed | 250 | 265 |
| Not completed | 28 | 14 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Adverse event | 9 | 0 |
| Withdrew: Withdrawal criteria | 16 | 11 |
| Withdrew: Unclassified | 1 | 1 |
Change from baseline in HbA1c after 26 weeks of treatment
| Percentage (%) | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | -1.81 ± 1.08 | -1.13 ± 0.98 |
Change from baseline in body weight after 26 weeks of treatment
| Kg | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) |
|---|---|---|
| Change From Baseline in Body Weight | -1.4 ± 3.5 | 1.8 ± 3.6 |
Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
| Number of episodes | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) |
|---|---|---|
| Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | 289 | 683 |
Collected over Week 0 to week 27 (26-week treatment period and a follow-up visit 1 week after end of treatment). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Degludec/Liraglutide (IDegLira) | — | 5/278 (1.8%) | 52/278 (18.7%) |
| Insulin Glargine (IGlar) | — | 9/279 (3.2%) | 22/279 (7.9%) |
| Event | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) |
|---|---|---|
| CholelithiasisHepatobiliary disorders | 1/278 | 0/279 |
| Postmenopausal haemorrhageReproductive system and breast disorders | 1/278 | 0/279 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/278 | 0/279 |
| Rectal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/278 | 0/279 |
| Vertebrobasilar insufficiencyNervous system disorders | 1/278 | 0/279 |
| Acute coronary syndromeCardiac disorders | 0/278 | 1/279 |
| AppendicitisInfections and infestations | 0/278 | 1/279 |
| ArrhythmiaCardiac disorders | 0/278 | 1/279 |
| Auricular perichondritisEar and labyrinth disorders | 0/278 | 1/279 |
| Biliary colicHepatobiliary disorders | 0/278 | 1/279 |
| Event | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) |
|---|---|---|
| NauseaGastrointestinal disorders | 26/278 | 3/279 |
| DiarrhoeaGastrointestinal disorders | 20/278 | 7/279 |
| VomitingGastrointestinal disorders | 14/278 | 5/279 |
| HeadacheNervous system disorders | 11/278 | 14/279 |
Full analysis set (FAS) was used for baseline measurements. FAS included all randomised subjects.
| Age, Continuous(Years) | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) | Total |
|---|---|---|---|
| Mean | 58.4 ± 9.8 | 59.1 ± 9.3 | 58.8 ± 9.5 |
| Sex: Female, Male(Participants) | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) | Total |
|---|---|---|---|
| Female | 135 | 142 | 277 |
| Male | 143 | 137 | 280 |
| Glycated hemoglobin (HbA1c)(Percentage (%)) | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) | Total |
|---|---|---|---|
| Mean | 8.4 ± 0.9 | 8.2 ± 0.9 | 8.3 ± 0.9 |
| Body weight(Kg) | Insulin Degludec/Liraglutide (IDegLira) | Insulin Glargine (IGlar) | Total |
|---|---|---|---|
| Mean | 88.3 ± 17.5 | 87.3 ± 15.8 | 87.8 ± 16.6 |
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Insulin degludec · Liraglutide