Trial reportExperimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association2005
Adjunctive therapy with pramlintide lowers HbA1c without concomitant weight gain and increased risk of severe hypoglycemia in patients with type 1 diabetes approaching glycemic targets.
Trial report in Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04133922 (Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.
- Age, sex, disease severity, and disease duration difference in placebo response: implications from a meta-analysis of diabetes mellitus.BMC medicine · 2020Pooled it
- Adjuvant Liraglutide and Insulin Versus Insulin Monotherapy in the Closed-Loop System in Type 1 Diabetes: A Randomized Open-Labeled Crossover Design Trial.Journal of diabetes science and technology · 2016Trial
- Impact of Disease Duration on the Effects of Pramlintide in Type 1 Diabetes: A Post Hoc Analysis of Three Clinical Trials.Advances in therapy · 2016Trial
- New Amylin-Based Agonists for the Treatment of Obesity and Type 2 Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Review
- The evolving therapeutic landscape of gut-pancreatic peptide signalling in metabolic disorders: from mono- to multi-agonist therapies.Bioscience reports · 2026Review
- A Critical Analysis of the FDA's Omics-Driven Pharmacodynamic Biomarkers to Establish Biosimilarity.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Ultra-Fast Insulin-Pramlintide Co-Formulation for Improved Glucose Management in Diabetic Rats.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2021Article
- Engineering biopharmaceutical formulations to improve diabetes management.Science translational medicine · 2021Review
- A co-formulation of supramolecularly stabilized insulin and pramlintide enhances mealtime glucagon suppression in diabetic pigs.Nature biomedical engineering · 2020Article
- Peptides from Natural or Rationally Designed Sources Can Be Used in Overweight, Obesity, and Type 2 Diabetes Therapies.Molecules (Basel, Switzerland) · 2020Review
- Amylin and Calcitonin: Potential Therapeutic Strategies to Reduce Body Weight and Liver Fat.Frontiers in endocrinology · 2020Review
- Metabolic Control in Type 1 Diabetes: Is Adjunctive Therapy the Way Forward?Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Review
- Adjunctive therapy for glucose control in patients with type 1 diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2018Review
- Role of sodium glucose cotransporter-2 inhibitors in type I diabetes mellitus.Diabetes, metabolic syndrome and obesity : targets and therapy · 2017Review
- Bowels control brain: gut hormones and obesity.Biochemia medica · 2012Review
- Peptides and their potential role in the treatment of diabetes and obesity.The review of diabetic studies : RDS · 2011Review
- Optimal control of blood glucose: the diabetic patient or the machine?Science translational medicine · 2010Article
- Pramlintide, the synthetic analogue of amylin: physiology, pathophysiology, and effects on glycemic control, body weight, and selected biomarkers of vascular risk.Vascular health and risk management · 2008Review
- Efficacy and harms of the hypoglycemic agent pramlintide in diabetes mellitus.Annals of family medicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsIn long-term clinical trials in patients with type 1 diabetes spanning a wide range of HbA1c, addition of pramlintide to existing insulin regimens led to reductions in HbA1c that were accompanied by weight loss and no increase in overall severe hypoglycemia event rates. Given that weight gain and increased hypoglycemia risk contribute to the difficulty of attaining HbA1c targets (<7 %), the question arose whether pramlintide could benefit patients approaching, but not reaching glycemic targets with insulin alone. To address this question, we conducted a pooled analysis from 3 long-term clinical trials, including all patients with an entry HbA1c between 7.0 % and 8.5 %.
methodsWithin the subset of patients with an entry HbA1c between 7.0 % and 8.5 % (approximately 28 % of all patients enrolled in the 3 studies), 196 were treated with placebo + insulin (baseline HbA1c 7.9+/-0.4 %, body weight 76.0+/-14.3 kg [mean+/-SD]) and 281 with pramlintide+insulin (baseline HbA1c 7.9+/-0.4 %, body weight 75.4+/-13.1 kg). Endpoints included placebo-corrected changes from baseline to week 26 in HbA1c, body weight, and the event rate of severe hypoglycemia.
resultsAdjunctive therapy with pramlintide resulted in significant reductions in HbA1c and body weight from baseline to week 26 (0.3 % and 1.8 kg, placebo-corrected treatment differences, respectively, both p<or=0.0009). These changes occurred without an increase in the overall risk of severe hypoglycemia (1.40 pramlintide vs. 1.86 placebo, events/patient-year of exposure).
conclusionsAddition of pramlintide to insulin therapy may help patients with type 1 diabetes who are approaching, but not yet reaching, glycemic targets with insulin alone to achieve further reductions in HbA1c without concomitant weight gain and increased risk of severe hypoglycemia.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.