Type 2 Diabetes MellitusPhase 4DiabetesNCT02680457
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Insulin Degludec and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Degludec and Insulin Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2013to Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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]
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of the Administration of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus Drug-naïve
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.
Read the detailed description
Cross-over, double dummy, randomized, clinical trial was carried out. The sample size was calculated using the formula for clinical trials of mean differences with an "n" of 6 patients per group was obtained. Patients between 30 and 65 years of age will be included with T2DM, without hyperglycemic drugs, hemoglobin A1c (A1C) 6.5 to 11.0 % and with written signature consent. They were assigned randomly by sealed envelope either to received insulin Degludec (Novo Nordisk A/S. Bagsvaerd, Denmark) or insulin Glargine (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany) [10 international units (IU) subcutaneous (SC) every 24 hours for six days], patients who were administered initially insulin Degludec corresponded then insulin Glargine and vice versa, with a washout period of 14 days between each intervention.
The clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline. Body weight, body mass index and blood pressure were performed during the initial visit, likewise, interstitial glucose concentrations by ambulatory continuous glucose monitoring system (Guardian®, Medtronic MiniMed, Northridge), through which the mean amplitude of glucose excursions (MAGE) and area under the curve of glucose were calculated, which served to assess the glycemic variability. Adverse events and adherence to treatment are documented. Statistical analysis: Mann-Whitney U test, Chi2, Fisher exact test. It is considered with significance at p <0.05.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Degludec, Insulin Glargine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin DegludecDrug
Also called Tresiba ® (Novo Nordisk A/S. Bagsvaerd, Denmark)
Insulin Degludec 10 IU SC every 24 hours for 6 days
Insulin GlargineDrug
Also called Lantus ® (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany)
Insulin Glargine 10 IU SC every 24 hours for 6 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Insulin Degludec; Drug: 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 Receives: Drug: Insulin Degludec; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Secondary outcomes (1)
Glycemic Variability: Area Under the Curve of Glucose
Area under the curve of glucose of the second day of continuous ambulatory glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge)
Measured: Every 5 min for 24 hours on day 5 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- MANUEL GONZALEZ, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680457
- Sponsor's protocol ID
- CT-DG-140282-JLRN
- Acronym
- Diabetes
- Status last verified
- Sep 2020
- First submitted
- 7 Dec 2015
- Last updated
- 28 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus Drug-naïve
- ClinicalTrials.gov ID
- NCT02680457
- Acronym / sponsor ID
- Diabetes / CT-DG-140282-JLRN
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Posted 28 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cross-over, double dummy, randomized, clinical trial was carried out. The sample size was calculated using the formula for clinical trials of mean differences with an "n" of 6 patients per group was obtained. Patients between 30 and 65 years of age will be included with T2DM, without hyperglycemic drugs, hemoglobin A1c (A1C) 6.5 to 11.0 % and with written signature consent. They were assigned randomly by sealed envelope either to received insulin Degludec (Novo Nordisk A/S. Bagsvaerd, Denmark) or insulin Glargine (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany) [10 international units (IU) subcutaneous (SC) every 24 hours for six days], patients who were administered initially insulin Degludec corresponded then insulin Glargine and vice versa, with a washout period of 14 days between each intervention.
The clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline. Body weight, body mass index and blood pressure were performed during the initial visit, likewise, interstitial glucose concentrations by ambulatory continuous glucose monitoring system (Guardian®, Medtronic MiniMed, Northridge), through which the mean amplitude of glucose excursions (MAGE) and area under the curve of glucose were calculated, which served to assess the glycemic variability. Adverse events and adherence to treatment are documented. Statistical analysis: Mann-Whitney U test, Chi2, Fisher exact test. It is considered with significance at p <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Degludec - Insulin Glargine | Active comparator | Drug: Insulin Degludec, Drug: Insulin GlargineInsulin 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 |
| Insulin Glargine - Insulin Degludec | Active comparator | Drug: Insulin Degludec, Drug: Insulin GlargineInsulin 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin DegludecAlso: Tresiba ® (Novo Nordisk A/S. Bagsvaerd, Denmark)Insulin Degludec 10 IU SC every 24 hours for 6 days | Drug | Insulin Degludec - Insulin Glargine, Insulin Glargine - Insulin Degludec |
| Insulin GlargineAlso: Lantus ® (Sanofi-Aventis Deutschland GmbH. Frankfurt, Germany)Insulin Glargine 10 IU SC every 24 hours for 6 days | Drug | Insulin Degludec - Insulin Glargine, Insulin Glargine - Insulin Degludec |
Primary outcome
Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE)
Time frame: 2 days
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
1 secondary outcome
Glycemic Variability: Area Under the Curve of Glucose
Time frame: Every 5 min for 24 hours on day 5 post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANUEL GONZALEZ, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Degludec and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.