The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004665-32-DE

Enrollment

320

Registered

2012-06-20

Start date

2012-09-18

Completion date

Unknown

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 MedDRA version: 16.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: IDeg PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin degludec CAS Number: 844439-96-9 Concentration unit: U/ml unit(s)/millilitre Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - = 18 years of age - Type 2 diabetes - Insulin naïve - Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only BID) - HbA1c (by central laboratory analysis): - 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy - 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 224 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 96

Exclusion criteria

Exclusion criteria: - Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks - Calcitonin = 50 pg/mL - Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia;Secondary Objective: To assess other efficacy parameters, safety and PROs of IDeg compared to placebo, both in combination with liraglutide and metformin;Primary end point(s): Change from baseline in HbA1c (%) ;Timepoint(s) of evaluation of this end point: After 26 weeks of randomised treatment	—

Measure

Time frame

Main Objective: To confirm the efficacy of IDeg compared to placebo, both in combination with liraglutide and metformin, in controlling glycaemia;Secondary Objective: To assess other efficacy parameters, safety and PROs of IDeg compared to placebo, both in combination with liraglutide and metformin;Primary end point(s): Change from baseline in HbA1c (%) ;Timepoint(s) of evaluation of this end point: After 26 weeks of randomised treatment

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary efficacy endpoints 1. Change from baseline in FPG 2. Number of responders for HbA1c (< 7.0 %) 3. Change from baseline in mean pre-breakfast measurements used for titration 4. Change from baseline in 8-point profile 5. Change from baseline in mean of the 8-point profile Key secondary safety endpoints 6. Number of hypoglycaemic episodes 7. Number of adverse events Key secondary PRO endpoint 8. Change from baseline in patient reported health-related quality of life;Timepoint(s) of evaluation of this end point: Key secondary efficacy endpoints 1.-5. after 26 weeks of randomised treatment Key secondary safety endpoints 6.-7. during 26 weeks of randomised treatment Key secondary PRO endpoint 8. after 26 weeks of randomised treatment using the Short-Form 36 Health Survey version 2 (SF-36®v2)	—

Measure

Time frame

Secondary end point(s): Key secondary efficacy endpoints 1. Change from baseline in FPG 2. Number of responders for HbA1c (< 7.0 %) 3. Change from baseline in mean pre-breakfast measurements used for titration 4. Change from baseline in 8-point profile 5. Change from baseline in mean of the 8-point profile Key secondary safety endpoints 6. Number of hypoglycaemic episodes 7. Number of adverse events Key secondary PRO endpoint 8. Change from baseline in patient reported health-related quality of life;Timepoint(s) of evaluation of this end point: Key secondary efficacy endpoints 1.-5. after 26 weeks of randomised treatment Key secondary safety endpoints 6.-7. during 26 weeks of randomised treatment Key secondary PRO endpoint 8. after 26 weeks of randomised treatment using the Short-Form 36 Health Survey version 2 (SF-36®v2)

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Countries

Canada, European Union, Germany, Israel, Italy, Serbia, South Africa, Ukraine, United Arab Emirates, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026