NCT02680457

Brief Summary

Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2013

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

September 28, 2020

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

December 7, 2015

Results QC Date

August 16, 2020

Last Update Submit

September 25, 2020

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE)

    Mean amplitude of interstitial glucose excursions (MAGE) during the last 48 h of the ambulatory continuous glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge); starting in the day 3 of the administration of insulin degludec or glargine

    2 days

Secondary Outcomes (1)

  • Glycemic Variability: Area Under the Curve of Glucose

    Every 5 min for 24 hours on day 5 post-dose

Study Arms (2)

Insulin Degludec - Insulin Glargine

ACTIVE COMPARATOR

Insulin Degludec 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Glargine 10 IU SC every 24 hours for 6 days

Drug: Insulin DegludecDrug: Insulin Glargine

Insulin Glargine - Insulin Degludec

ACTIVE COMPARATOR

Insulin Glargine 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Degludec 10 IU SC every 24 hours for 6 days

Drug: Insulin DegludecDrug: Insulin Glargine

Interventions

Insulin DegludecDRUG

Insulin Degludec 10 IU SC every 24 hours for 6 days

Also known as: Tresiba ® (Novo Nordisk A/S. Bagsvaerd, Denmark)
Insulin Degludec - Insulin GlargineInsulin Glargine - Insulin Degludec
Insulin GlargineDRUG

Insulin Glargine 10 IU SC every 24 hours for 6 days

Also known as: Lantus ® (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany)
Insulin Degludec - Insulin GlargineInsulin Glargine - Insulin Degludec

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from 25.0-34.9 kg/m2 Diagnosis of T2DM
  • Fasting plasma glucose ≤300 mg/dL at the time of scrutiny
  • A1C between 6.5 and 11%
  • Written informed consent

You may not qualify if:

  • Women pregnant or breastfeeding
  • Untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\]
  • Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose. In the case of antihypertensives, these may be included if treatment was not modified previous 3 months and no change during the study.
  • Total cholesterol \>240 mg/dL
  • Triglycerides ≥400 mg/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than twice the normal range
  • Glomerular filtration rate \<60 mL/min \[Cockcroft-Gault\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludecInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

There were technical problems with the measurement of the outcomes. Design errors and protocol violations were detected at the end of the study. Therefore, the results are considered unreliable.

Results Point of Contact

Title
Dr. Manuel González Ortiz
Organization
Instituto de Terapéutica Experimental y Clínica, Universidad de Guadalajara
uiec@prodigy.net.mx
+52 3310585200

Study Officials

  • MANUEL GONZALEZ, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 7, 2015

First Posted

February 11, 2016

Study Start

November 1, 2013

Primary Completion

July 1, 2015

Study Completion

November 1, 2016

Last Updated

September 28, 2020

Results First Posted

September 28, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)