Trial · NCT03078478
A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
NCT03078478, Phase 3, Completed, Novo Nordisk A/S; results first posted 2020-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs. Trials, record NCT03078478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03078478
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
- NCT number
- NCT03078478
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,609 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Interventions
- Insulin degludec, Insulin glargine
- First posted
- 2017-03-13
- Last updated
- 2022-01-11
- Other registries' IDs
- eudract:2016-002801-20
- Results first posted
- 2020-03-12
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 Weeks | Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. |
| Secondary | Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks) | 88 weeks | The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks). |
| Secondary | Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 weeks | Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. |
| Secondary | Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 weeks (maintenance 2) | Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results. |
| Secondary | Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88). |
| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88). |
| Secondary | Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) | At 88 weeks | Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks). |
| Secondary | Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) | At 88 weeks | Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks). |
| Secondary | Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) | End of Treatment (up to 88 Weeks) | Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks). |
| Secondary | Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) | At 88 weeks | Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 Weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks) | 88 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data. | Units | MEAN |
| SECONDARY | Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 weeks (maintenance 2) | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | The full analysis set (FAS) comprised all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of HbA1c | MEAN |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) | At 88 weeks | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) | At 88 weeks | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) | End of Treatment (up to 88 Weeks) | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) | At 88 weeks | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | Insulin Degludec 200 | 216.8 | Episodes/(PYE*100) | ||
| Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | Insulin Glargine U300 | 243.9 | Episodes/(PYE*100) | ||
| Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks) | Insulin Degludec 200 | 66.6 | Standard Deviation 48.54 | Units | |
| Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks) | Insulin Glargine U300 | 73.0 | Standard Deviation 48.48 | Units | |
| Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | Insulin Degludec 200 | 62.30 | Episodes/(PYE*100) | ||
| Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | Insulin Glargine U300 | 93.75 | Episodes/(PYE*100) | ||
| Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | Insulin Degludec 200 | 0.98 | Episodes/(PYE*100) | ||
| Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | Insulin Glargine U300 | 4.88 | Episodes/(PYE*100) | ||
| Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks) | Insulin Degludec 200 | -0.54 | Standard Deviation 0.91 | Percentage of HbA1c | |
| Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks) | Insulin Glargine U300 | -0.46 | Standard Deviation 0.90 | Percentage of HbA1c |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Period (16 Weeks) | STARTED | Insulin Degludec U200 | 805 | |
| Titration Period (16 Weeks) | STARTED | Insulin Glargine U300 | 804 | |
| Titration Period (16 Weeks) | Full Analysis Set | Insulin Degludec U200 | 805 | |
| Titration Period (16 Weeks) | Full Analysis Set | Insulin Glargine U300 | 804 | |
| Titration Period (16 Weeks) | Safety Analysis Set | Insulin Degludec U200 | 802 | |
| Titration Period (16 Weeks) | Safety Analysis Set | Insulin Glargine U300 | 798 | |
| Titration Period (16 Weeks) | COMPLETED | Insulin Degludec U200 | 805 | |
| Titration Period (16 Weeks) | COMPLETED | Insulin Glargine U300 | 804 | |
| Titration Period (16 Weeks) | NOT COMPLETED | Insulin Degludec U200 | 0 | |
| Titration Period (16 Weeks) | NOT COMPLETED | Insulin Glargine U300 | 0 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events646
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | IDeg U200 | 51 | 802 | 59 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | IGlar U300 | 65 | 798 | 84 |
| other | Back pain | Musculoskeletal and connective tissue disorders | IDeg U200 | 59 | 802 | 73 |
| other | Back pain | Musculoskeletal and connective tissue disorders | IGlar U300 | 62 | 798 | 70 |
| other | Bronchitis | Infections and infestations | IDeg U200 | 48 | 802 | 54 |
| other | Bronchitis | Infections and infestations | IGlar U300 | 46 | 798 | 46 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | IDeg U200 | 48 | 802 | 60 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | IGlar U300 | 46 | 798 | 53 |
| other | Diarrhoea | Gastrointestinal disorders | IDeg U200 | 72 | 802 | 90 |
| other | Diarrhoea | Gastrointestinal disorders | IGlar U300 | 79 | 798 | 97 |
1 to 10 of 646Source ClinicalTrials.gov
See all 646 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IDeg U200 | 7 | 802 |
| Total, all-cause mortality | IGlar U300 | 9 | 798 |
| Total, other adverse events | IDeg U200 | 496 | 802 |
| Total, other adverse events | IGlar U300 | 476 | 798 |
| Total, serious adverse events | IDeg U200 | 167 | 802 |
| Total, serious adverse events | IGlar U300 | 141 | 798 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IDeg U200 vs IGlar U300: deaths from any cause | Trial comparisons |
| IDeg U200 vs IGlar U300: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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