NCT02501161|CompletedPhase 3Results

A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

DUAL™ VIII

A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9068-42282014-005639-15U1111-1165-3914

Study Type

interventional

Target

1,012

Locations

16 countries

Sites

143

Timeline

RegisteredJul 2015

StartedJan 2016

CompletionOct 2018

Brief Summary

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,012

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Jan 2016

Longer than P75 for phase_3 diabetes

Geographic Reach

16 countries

143 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

July 15, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed

7 months until next milestone

Study Start

First participant enrolled

January 31, 2016

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2019

Completed

Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

2.7 years

First QC Date

July 15, 2015

Results QC Date

October 3, 2019

Last Update Submit

November 8, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.
Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

Secondary Outcomes (53)

Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits
Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2
Change in HbA1c
Week 0, week 26
Change in Body Weight
Week 0, week 26, week 104
Insulin Dose
Week 26, week 104
Participants Who Achieved (Yes/no): HbA1c <7.0%
Week 26, week 104
+48 more secondary outcomes

Study Arms (2)

Insulin degludec/liraglutide QD + OAD(s)

EXPERIMENTAL

Drug: insulin degludec/liraglutide

insulin glargine QD + OAD(s)

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludec/liraglutideDRUG

Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.

Insulin degludec/liraglutide QD + OAD(s)

insulin glargineDRUG

Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.

insulin glargine QD + OAD(s)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Subjects diagnosed with type 2 diabetes mellitus
HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
Body mass index greater than or equal to 20 kg/m\^2
Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)

You may not qualify if:

Screening calcitonin greater than or equal to 50 ng/L
Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening
Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal
Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
History of pancreatitis (acute or chronic)
Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Contact the study team to confirm eligibility.