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Trial record 67 of 199 for:    Protamine

Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin

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ClinicalTrials.gov Identifier: NCT04034524
Recruitment Status : Active, not recruiting
First Posted : July 26, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Jing Luo, Brigham and Women's Hospital

Brief Summary:
This study will compare hemoglobin a1c (HbA1c) and cardiovascular (CV) outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: GLP-1 receptor agonist Drug: Insulin

Detailed Description:
The 2019 ADA-EASD clinical treatment guidelines recommend a GLP-1RA over basal insulin for patients with type 2 diabetes with suboptimal glycemic control despite metformin and a second-line glucose lowering agent. The basis of this recommendation is due to the side effect profiles of these two medications (i.e. reduced risk of hypoglycemia, some weight loss with GLP-1RA), convenience (once weekly injection) and the fact that the price of insulin has skyrocketed in recent years. Prior head-to-head randomized trials (EAGLE, LEAD 5) comparing select GLP-1RA and basal insulin have found mixed results. In EAGLE, adding either insulin glargine or liraglutide to patients with poorly controlled type 2 diabetes found no differences in the primary outcome (percentage of people reaching HbA1c < 7%). In LEAD 5, liraglutide was associated with a slightly greater HbA1c reduction than glargine, however the dose of insulin was approximately 50% less than the dose used in EAGLE. The objective of this observational study is to describe the comparative effectiveness and safety of newly initiating a GLP1RA versus basal insulin in patients with type 2 diabetes using metformin and another oral glucose lowering medicine.

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Study of Glycemic Control and Cardiovascular Outcomes Among Patients With Type 2 Diabetes Newly Initiating Glucagon-like Peptide-1 Receptor Agonists (GLP1) Versus Basal Insulin in Routine Care Settings
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
New users of GLP1 receptor agonists (exposure) Drug: GLP-1 receptor agonist
any GLP-1 receptor agonist (other than Saxenda or liraglutide 3.0mg)

New users of basal insulin (reference) Drug: Insulin
glargine, detemir, neutral protamine Hagedorn (NPH), degludec
Other Name: Basal Insulin




Primary Outcome Measures :
  1. Time until first composite CV event (myocardial infarction, stroke) [ Time Frame: Through Study Completion, an estimated average of 1 year ]

Secondary Outcome Measures :
  1. Time until first myocardial infarction [ Time Frame: Through Study Completion, an estimated average of 1 year ]
  2. Time until first stroke [ Time Frame: Through Study Completion, an estimated average of 1 year ]
  3. Time until first serious hypoglycemic event [ Time Frame: Through Study Completion, an estimated average of 1 year ]
  4. Time until first episode of acute pancreatitis [ Time Frame: Through Study Completion, an estimated average of 1 year ]
  5. Time until first episode of acute cholecystitis [ Time Frame: Through Study Completion, an estimated average of 1 year ]

Other Outcome Measures:
  1. Proportion of patients with HbA1c post-index < 7% (EAGLE) [ Time Frame: 24 weeks ]
  2. Proportion of patients with HbA1c post-index < 8% (EAGLE) [ Time Frame: 24 weeks ]
  3. Change from baseline HbA1c [ Time Frame: 24 weeks ]
    Weighted mean



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes with prior and concomitant use of metformin and other oral anti diabetic agents
Criteria

Inclusion Criteria:

  • Age>=18 years
  • at least 180 days of continuous enrollment prior to index date
  • at least 1 Type 2 diabetes diagnosis code prior to index date
  • (for cohort #1) at least 2 metformin dispensings prior to index date AND days supply overlap on cohort entry date (with 14 days of grace period before)

Exclusion Criteria:

  • any type 1 diabetes diagnosis code prior to index date
  • medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (both black box warnings) prior to index date
  • h/o pancreatitis
  • h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / emergency department encounter in primary diagnosis position for hypoglycemia)
  • index injectable is a combination of GLP1-RA plus insulin
  • index GLP1-RA is Saxenda (indicated for weight loss) or liraglutide at 3.0mg dose
  • index insulin regimen includes both basal and prandial insulin, or premixed insulin
  • Any prior GLP1-RA use (Applied washout for 180 days)
  • Any prior insulin use; Sometimes insulin is transiently used at diagnosis (Applied washout for 180 days)
  • Secondary diabetes
  • Gestational diabetes
  • Nursing home admission (because we don't have pharmacy claims)
  • Age <18 years
  • Chronic kidney disease stage 4-6
  • Advanced cancer
  • End stage renal disease

For A1c cohort only:

-HbA1c >12%


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034524


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02138
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Study Chair: Jessica M Franklin, PHD Brigham and Women's Hospital

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Responsible Party: Jing Luo, Instructor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04034524     History of Changes
Other Study ID Numbers: 2011P002580-118
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents