NCT00851903|CompletedPhase 3Results

Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin

Sanofi ClinicalTrials.gov

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2 other identifiers

EXT_LANTU_C_027612008-000521-19

Study Type

interventional

Target

112

Locations

16 countries

Sites

Timeline

RegisteredFeb 2009

StartedJun 2009

CompletionSep 2011

Brief Summary

This study was the extension of the LANTU\_C\_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled). All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria. The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period. The objectives of this extension study were:

To assess the glycemic control (HbA1c \<7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.
To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.

Trial Health

On Track

Trial Health Score

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

Enrollment

112

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Jun 2009

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach

16 countries

16 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

February 25, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed

3 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 4, 2012

Completed

Last Updated

October 4, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

February 25, 2009

Results QC Date

September 3, 2012

Last Update Submit

September 3, 2012

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)
study endpoint: week 12 or earlier in case of premature discontinuation

Secondary Outcomes (6)

HbA1c: Change From Baseline to Study Endpoint
baseline, study endpoint: week 12 or earlier in case of premature discontinuation
Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
baseline, study endpoint: week 12 or week 8 if value not available at week 12
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
baseline, study endpoint: week 12 or week 8 if value not available at week 12
Insulin Dose
baseline, week 4, week 8, week 12
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
During the treatment period (12 weeks) plus 7 days after last dose
+1 more secondary outcomes

Study Arms (1)

Combination insulin glargine and sitagliptin

EXPERIMENTAL

Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \< Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \<FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food.

Drug: Insulin GlargineDrug: SitagliptinDrug: Metformin

Interventions

Insulin GlargineDRUG

Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).

Also known as: Lantus®

Combination insulin glargine and sitagliptin

SitagliptinDRUG

Oral administration. 100mg film-coated tablets.

Also known as: Januvia®

Combination insulin glargine and sitagliptin

MetforminDRUG

Patients continued with metformin as usual oral anti-diabetic treatment.

Combination insulin glargine and sitagliptin

Eligibility Criteria

Age35 Years - 71 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients who completed the core study LANTU\_C\_02761 (NCT00751114) i.e. went through the visit 14 investigation,
HbA1c \>= 7 %,
Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,
Signed informed consent obtained prior any study procedure,
Willingness and ability to comply with the study protocol.

You may not qualify if:

Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
Treatment with a non-permitted drug during the core study,
Pregnant or lactating women,
In-patient care,
Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry in the core study),
Impaired renal function: serum creatinine \>= 1.5 mg/dL (\>= 133µmol/L) or \>= 1.4 mg/dL (\>=124 µmol/L) in men and women, respectively,
History of sensitivity to the study drugs or to drugs with a similar chemical structure,
Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 x upper limit of normal range,
Alcohol or drug abuse within the last year,
Night shift worker,
Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant),
History of pancreatitis.

Contact the study team to confirm eligibility.