A Phase 3 interventional study of insulin degludec/liraglutide and placebo in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 87 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 435 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: insulin degludec/liraglutide
Drug: placebo
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Injected subcutaneously (under the skin) once daily.
Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from baseline to 26 weeks.
Time frame: Week 0, Week 26
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Percentage of subjects having HbA1c below 7% at week 26.
Time frame: Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Percentage of subjects having HbA1c below 6.5% at week 26
Time frame: Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG at week 26.
Time frame: Week 0, week 26
Change From Baseline in Body Weight
Change from baseline in body weight at week 26.
Time frame: Week 0, week 26
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration. Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor. Minor hypoglycaemic episodes were defined as: 1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself. 2. Any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or blood glucose value \<2.8 mmol/L (50 mg/dL). Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).
Time frame: After 26 weeks of treatment
Number of Adverse Events (AEs)
An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.
Time frame: After 26 weeks of treatment
The trial was conducted at 77 sites in 7 countries: Bulgaria (7), Canada (9), Germany (6), India (6), Israel (7), Turkey (3), United States (39).
| Milestone | IDegLira | Placebo |
|---|---|---|
| Started | 289 | 146 |
| Exposed | 288 | 146 |
| Completed | 251 | 111 |
| Not completed | 38 | 35 |
| Withdrew: Protocol violation | 13 | 10 |
| Withdrew: Adverse event | 9 | 2 |
| Withdrew: Withdrawal criteria | 2 | 10 |
| Withdrew: Unclassified | 14 | 13 |
Change in HbA1c from baseline to 26 weeks.
| percentage of glycosylated haemoglobin | IDegLira | Placebo |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | -1.45 ± 0.84 | -0.46 ± 0.83 |
Percentage of subjects having HbA1c below 7% at week 26.
| percentage of subjects | IDegLira | Placebo |
|---|---|---|
| Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) | 79.2 | 28.8 |
Percentage of subjects having HbA1c below 6.5% at week 26
| percentage of subjects | IDegLira | Placebo |
|---|---|---|
| Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) | 64 | 12.3 |
Change from baseline in FPG at week 26.
| mmol/L | IDegLira | Placebo |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | -2.6 ± 2.61 | -0.31 ± 2.43 |
Change from baseline in body weight at week 26.
| kilogram | IDegLira | Placebo |
|---|---|---|
| Change From Baseline in Body Weight | 0.5 ± 3.1 | -1 ± 2.6 |
An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration. Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor. Minor hypoglycaemic episodes were defined as: 1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself. 2. Any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or blood glucose value \<2.8 mmol/L (50 mg/dL). Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).
| event rate per 100 PYE | IDegLira | Placebo |
|---|---|---|
| Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes | 351.7 | 135.2 |
An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.
| event rate per 100 PYE | IDegLira | Placebo |
|---|---|---|
| Number of Adverse Events (AEs) | 401.4 | 367 |
Collected over After 26 weeks of treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IDegLira | — | 14/288 (4.9%) | 83/288 (28.8%) |
| Placebo | — | 5/146 (3.4%) | 38/146 (26%) |
| Event | IDegLira | Placebo |
|---|---|---|
| FallInjury, poisoning and procedural complications | 2/288 | 0/146 |
| Atrioventricular block second degreeCardiac disorders | 0/288 | 1/146 |
| BronchitisInfections and infestations | 0/288 | 1/146 |
| Dengue feverInfections and infestations | 0/288 | 1/146 |
| Impaired gastric emptyingGastrointestinal disorders | 0/288 | 1/146 |
| Stab woundInjury, poisoning and procedural complications | 0/288 | 1/146 |
| Acute myocardial infarctionCardiac disorders | 1/288 | 0/146 |
| Amylase increasedInvestigations | 1/288 | 0/146 |
| Anal abscessInfections and infestations | 1/288 | 0/146 |
| ArrhythmiaCardiac disorders | 1/288 | 0/146 |
| Event | IDegLira | Placebo |
|---|---|---|
| Lipase increasedInvestigations | 27/288 | 6/146 |
| NasopharyngitisInfections and infestations | 25/288 | 12/146 |
| DyslipidaemiaMetabolism and nutrition disorders | 19/288 | 6/146 |
| HeadacheNervous system disorders | 15/288 | 8/146 |
| InfluenzaInfections and infestations | 8/288 | 8/146 |
Full analysis set (FAS) included all randomized subjects.
| Age, Continuous(years) | IDegLira | Placebo | Total |
|---|---|---|---|
| Mean | 60 ± 9.6 | 59.4 ± 10.8 | 59.8 ± 10.0 |
| Sex: Female, Male(Participants) | IDegLira | Placebo | Total |
|---|---|---|---|
| Female | 135 | 73 | 208 |
| Male | 154 | 73 | 227 |
| Glycosylated haemoglobin(percentage of glycosylated haemoglobin) | IDegLira | Placebo | Total |
|---|---|---|---|
| Mean | 7.9 ± 0.6 | 7.9 ± 0.6 | 7.9 ± 0.6 |
| Fasting plasma glucose(mmol/L) | IDegLira | Placebo | Total |
|---|---|---|---|
| Mean | 9.1 ± 2.2 | 9.1 ± 2.1 | 9.1 ± 2.1 |
| Body weight(kilograms) | IDegLira | Placebo | Total |
|---|---|---|---|
| Mean | 87.2 ± 18.6 | 89.3 ± 17.5 | 87.9 ± 18.2 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S